Summary of PICO - Department of Health | Welcome to the ...
RATIFIED PICOApplication 1608:Amnion membrane (human tissue) for topical treatment of ophthalmic disorders (caused by disease and/or trauma to the cornea), and wound dressings for skin burns and ulcers on the craniofacial area, torso, and limbsSummary of PICO/PPICO criteria to define the question(s) to be addressed in an Assessment Report to the Medical Services Advisory Committee (MSAC)ComponentDescriptionPatientsPopulation 1: Ophthalmic conditionsFirst line treatment: Ophthalmic condition where cells on the corneal surface are disrupted (including chemical trauma, chemical burns, thermal burns, radiation burns, Stevens Johnson Syndrome, toxic epidermal necrosis, surgery removing the epithelium of the cornea; e.g. pterygium surgery)Second line treatment: Other corneal wounds which have failed to healInterventionAmnion membrane tissue grafts ComparatorSupportive care (chemical trauma, chemical burns, thermal burns, radiation burns, Stevens-Johnson Syndrome, toxic epidermal necrosis, surgery removing the epithelium of the cornea excluding pterygium surgery, chronic corneal wounds)Conjunctiva autografting (pterygium surgery) OutcomesPatient relevant outcomesAny adverse events associated with amnion membrane, including infection rates and donor derived infectionsAny adverse events associated with comparators, including infection ratesWound healing (rate of frequency of compete healing; time to healing)Visual acuity PainTime to return to work/activityLength of hospital stayDisease recurrence (particularly for pterygium surgery)Quality of lifeHealthcare system outcomesCosts associated with the intervention, including resource use to deliver intervention and follow-up costsCosts associated with the comparator, including resource use to deliver intervention and follow-up costsChanges in utilisation of healthcare costs during follow-up period (for example: due to changes in hospitalisation rates and length; those required to treat adverse events)ComponentDescriptionPatientsPopulation 2: Chronic skin ulcers, where chronic is defined as unresponsive to treatment for at least six weeksInterventionAmnion membrane tissue grafts ComparatorUrgoStart dressing (diabetic foot and venous insufficiency ulcers)Split thickness skin grafts (diabetic foot ulcers, venous insufficiency ulcers)OutcomesPatient relevant outcomesAny adverse events associated with amnion membrane including any infection rates and donor derived infectionsAny adverse events associated with comparators including any infection ratesWound healing (change in wound size, rate of healing frequency of compete healing, time to healing)Scarring and cosmesis outcomesPainPatient movement Limb salvage ratesAmputation ratesTime to return to work/activityLength of hospital stayQuality of lifeHealthcare system outcomesCosts associated with the intervention including resource use to deliver intervention and follow-up costsCosts associated with the comparator including resource use to deliver intervention and follow-up costsChanges in utilisation of healthcare costs during follow-up period (for example: due to changes in hospitalisation rates and length; those required to treat adverse events)ComponentDescriptionPatientsPopulation 3: Acute skin wounds burns where patients require dermal substitute before skin grafting can take placepatients with a graft donor site wound; patients requiring a skin graft fixatorpatients with toxic epidermal necrolysis skin lesions requiring dressingInterventionAmnion membrane tissue graftsComparatorDermal substitutes (Integra and Novosorb BTM) (Population 3a)Standard wound dressing (Population 3b)Traditional fixation methods (e.g. staples, stiches, micropoous tape) (Population 3c)Biobrane (Population 3d)OutcomesPatient-relevant outcomesAny adverse events associated with amnion membrane including any infection rates and donor derived infectionsAny adverse events associated with comparators including any infection ratesWound healing (change in wound size, rate of healing frequency of compete healing, time to healing)Graft loss rates/graft takeScarring and cosmesis outcomesPainPatient movement Time to return to work/activityLength of hospital stayQuality of lifeHealthcare system outcomesCosts associated with the intervention, including resource use to deliver intervention and follow-up costsCosts associated with the comparator, including resource use to deliver intervention and follow-up costsChanges in utilisation of healthcare costs during follow-up period (for example: due to changes in hospitalisation rates and length; those required to treat adverse events)PICO or PPICO rationale for therapeutic and investigative medical services onlyPopulationThe Applicant proposed three populations:Ophthalmic conditions:First line treatment: Ophthalmic condition where cells on the corneal surface are disrupted (including chemical trauma, chemical burns, thermal burns, radiation burns, Stevens-Johnson Syndrome, toxic epidermal necrosis, surgery removing the epithelium of the cornea e.g. pterygium surgery)Second line treatment: other corneal wounds which have failed to healChronic ulcers where chronic is defined as unresponsive to treatment for at least six weeksAcute wounds for:burns where patients require dermal substitute before skin grafting can take placepatients with a graft donor site wound; patients requiring a skin graft fixatorpatients with toxic epidermal necrolysis skin lesions requiring dressingPASC noted the application is seeking listing of amnion membrane (human tissue) on Part B of the Prostheses List (PL) and required a health technology assessment (HTA), as currently there are no similar amnion membrane products listed on Part B of the PL. PASC noted the PICO included three (3) separate populations, each with subpopulations.PASC noted that the assessment group sought clarification of whether the three patient populations presented as three separated PICOs should be considered as separate applications. PASC acknowledged the difficulty in assessing several populations with subgroups in a single submission. However, PASC was concerned that separating the application by populations may impact the ability of MSAC to provide HTA advice to the Prostheses List Advisory Committee (PLAC) on the suitability of listing amnion membrane on Part B of the PL. Therefore, PASC advised that the application should continue to progress as a single submission, ensuring subgroups analysis is carried out, where data permits. Population 1: Ophthalmic conditionsPopulation 1 covers a range of ophthalmic conditions, which may cause the corneal surface to be disrupted. The corneal epithelium is comprised of five to seven layers of cells, which control corneal permeability to maintain the tear film. Generally, corneal-epithelium turnover is quick and rapid healing is possible ADDIN EN.CITE <EndNote><Cite><Author>Lee</Author><Year>2016</Year><RecNum>5</RecNum><DisplayText>(Lee, 2016)</DisplayText><record><rec-number>5</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334434">5</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Lee, Tarah</author></authors></contributors><titles><title>The Ins and Outs of Corneal Wound Healing</title></titles><volume>2020</volume><number>16 March</number><dates><year>2016</year></dates><publisher>Review of Ophthalmology</publisher><urls><related-urls><url>;(Lee, 2016). This is consistent with expert advice that, in normal circumstances, corneal wounds heal quickly. Expert advice is that amnion membrane products are most relevant for difficult cases where there is no clear therapeutic approach ADDIN EN.CITE <EndNote><Cite><Author>Associate Professor of Ophthalmology</Author><Year>2020</Year><RecNum>1</RecNum><DisplayText>(Associate Professor of Ophthalmology, 2020)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584333988">1</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Associate Professor of Ophthalmology,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by an Associate Professor of Ophthalmology, phone call, 27 February 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(Associate Professor of Ophthalmology, 2020). The expert also noted that the goal of treatment is a clear cornea and that difficult to treat cases lead to impaired vision or blindness if healing is not achieved.PASC noted that Population 1 in the draft PICO defined the use of amnion membrane as a first line treatment in patients with disruption of the corneal surface due to: chemical, thermal and radiation burns; Sevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrosis; pterygium surgery; or other ophthalmic surgeries where the cornea is removed. PASC noted that this population also proposed the use of amnion membrane, a second line treatment in patients with chronic ophthalmic conditions where the corneal wound is refractory to treatment.PASC advised that the use of amnion membrane in acute ophthalmic conditions (e.g. trauma) should be considered separately to its use in chronic ophthalmic conditions (e.g.?SJS). Chemical, thermal and radiation burnsChemical and thermal burns to the eye most commonly occur in young men following accidental exposure ADDIN EN.CITE <EndNote><Cite><Author>Hemmati</Author><Year>2020</Year><RecNum>6</RecNum><DisplayText>(Hemmati and Colby, 2020)</DisplayText><record><rec-number>6</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334734">6</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Hemmati, H.</author><author>Colby, K.</author></authors></contributors><titles><title>Treating Acute Chemical Injuries of the Cornea</title></titles><volume>2020</volume><number>16 March</number><dates><year>2020</year></dates><publisher>American Academy of Ophthalmology</publisher><urls><related-urls><url>;(Hemmati and Colby, 2020). Burns to the eye represent a medical emergency and require immediate emergency response, including irrigation and normalisation of the ocular pH in the case of chemical burns. After transfer to hospital, acute care is provided based on the severity of the injury as determined in an ophthalmic exam.Corneal damage can also be caused by radiation. Most commonly, this is due to ultraviolet (UV) light causing photokeratitis. Photokeratitis is often caused by exposure to reflected natural UV rays (e.g. reflected sun from snow, sand and water) or can be due to man-made UV rays (e.g. from sun bead or arc welding) ADDIN EN.CITE <EndNote><Cite><Author>Porter</Author><Year>2020</Year><RecNum>54</RecNum><DisplayText>(Porter and Pagan-Duran, 2020, Solano, 2019)</DisplayText><record><rec-number>54</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584921359">54</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Porter, A.</author><author>Pagan-Duran, B.</author></authors></contributors><titles><title>What is Photokeratitis — Including Snow Blindness? </title></titles><volume>2020</volume><number>23 March</number><dates><year>2020</year></dates><publisher>American Academy of Ophthalmology</publisher><urls><related-urls><url> app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584921452">55</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Solano, J</author></authors></contributors><titles><title>Ocular Burns and Chemical Injuries</title></titles><volume>2020</volume><number>23 March</number><dates><year>2019</year></dates><publisher>Medscape</publisher><urls><related-urls><url>;(Porter and Pagan-Duran, 2020, Solano, 2019). Similarly, ionising radiation exposure (X-ray, radioactive isotopes and medical radioactive sources) can also lead to ophthalmic radiation burns which cause corneal damage. In some cases this can lead to scar formation and corneal opacification ADDIN EN.CITE <EndNote><Cite><Author>Ingraham</Author><Year>2003</Year><RecNum>56</RecNum><DisplayText>(Ingraham et al., 2003)</DisplayText><record><rec-number>56</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584921507">56</key></foreign-keys><ref-type name="Book Section">5</ref-type><contributors><authors><author>Ingraham, H. J.</author><author>Donnenfeld, E. D.</author><author>Abramson, D. H.</author></authors><secondary-authors><author>Sagerman, Robert H.</author><author>Alberti, Winfried E.</author></secondary-authors></contributors><titles><title>Effects of Ionizing Radiation on the Conjunctiva, Cornea, and Lens</title><secondary-title>Radiotherapy of Intraocular and Orbital Tumors</secondary-title></titles><pages>201-211</pages><dates><year>2003</year><pub-dates><date>2003//</date></pub-dates></dates><pub-location>Berlin, Heidelberg</pub-location><publisher>Springer Berlin Heidelberg</publisher><isbn>978-3-642-55910-5</isbn><urls><related-urls><url>;(Ingraham et al., 2003)Burns can be categorised as ADDIN EN.CITE <EndNote><Cite><Author>Hemmati</Author><Year>2020</Year><RecNum>6</RecNum><DisplayText>(Hemmati and Colby, 2020)</DisplayText><record><rec-number>6</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334734">6</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Hemmati, H.</author><author>Colby, K.</author></authors></contributors><titles><title>Treating Acute Chemical Injuries of the Cornea</title></titles><volume>2020</volume><number>16 March</number><dates><year>2020</year></dates><publisher>American Academy of Ophthalmology</publisher><urls><related-urls><url>;(Hemmati and Colby, 2020):Grade 1: injury confined to corneal epithelium, cornea is totally clearGrade 2: mild corneal glaze, anterior chamber structures visible, focal limbal ischemiaGrade 3: significant ischemia of limbus, profound corneal glaze prohibiting visibility of anterior chamber structuresGrade 4: total loss of limbal stem cells, destruction of proximal conjunctival epithelium, corneal opaque and porcelainised.The goal of treatment is to support corneal healing while decreasing pain, inflammation and infection PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Bc3NvY2lhdGUgUHJvZmVzc29yIG9mIE9waHRoYWxtb2xv
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ADDIN EN.CITE.DATA (Associate Professor of Ophthalmology, 2020, Hemmati and Colby, 2020, Solano, 2019). Supportive care for all grade of injuries involves prophylactic antibiotics, topical steroids, topical cycloplegic agents and oral pain relief as required. For Grade 2-4 injuries oral tetracycline may be used to reduce corneal melting, in addition, debridement of necrotic tissue may be required. Steroids are used more frequently with higher grade injuries (four time per day for Grade 1 compared to hourly application for more severe injuries). Ophthalmic follow-up for patients would typically be every 2-3 days while an inpatient, then at 1-2 weeks post-discharge, transitioning to monthly appointments with the ophthalmologist as healing progresses. Patients would continue to receive ophthalmic follow-up 1-2 years post-injury.Expert advice is that currently, amnion membrane is more established for patients who do not achieve satisfactory healing with 1-2 weeks of supportive care, but emerging research is that amnion may be indicated for acute use in Grade 2-4 injuries ADDIN EN.CITE <EndNote><Cite><Author>Associate Professor of Ophthalmology</Author><Year>2020</Year><RecNum>1</RecNum><DisplayText>(Associate Professor of Ophthalmology, 2020)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584333988">1</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Associate Professor of Ophthalmology,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by an Associate Professor of Ophthalmology, phone call, 27 February 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(Associate Professor of Ophthalmology, 2020).Data from the Australian Institute of Health and Welfare (AIHW) indicates that 221 hospitalisation for eye burns were recorded in 2013/14 ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2016</Year><RecNum>7</RecNum><DisplayText>(AIHW et al., 2016)</DisplayText><record><rec-number>7</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334910">7</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW,</author><author>Pointer, S.</author><author>Tovell, A.</author></authors></contributors><titles><title>Hospitalised burn injuries, Australia, 2013–14. Injury research and statistics series no. 102. Cat. no. INJCAT 178</title></titles><volume>2020</volume><number>16 March</number><dates><year>2016</year></dates><pub-location>Canberra</pub-location><publisher>Australian Institute of Health and Welfare</publisher><urls><related-urls><url>;(AIHW et al., 2016). The grade of these injuries is not known; therefore, this presents an upper limit to the number of amnion membrane products that could be expected to be used in this subpopulation. Stevens-Johnson Syndrome and Toxic Epidermal NecrosisStevens-Johnson Syndrome (SJS) is an inflammatory disorder which targets the skin and mucous membranes ADDIN EN.CITE <EndNote><Cite><Author>Slentz</Author><Year>2013</Year><RecNum>8</RecNum><DisplayText>(Slentz and Hemmati, 2013)</DisplayText><record><rec-number>8</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584335048">8</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Slentz, D.</author><author>Hemmati, H.</author></authors></contributors><titles><title>Management of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis</title></titles><volume>2020</volume><number>16 March</number><dates><year>2013</year></dates><publisher>American Academy of Ophthalmology</publisher><urls><related-urls><url>;(Slentz and Hemmati, 2013). The disease is characterised by blistering and necrosis which can be life threatening. Toxic epidermal necrosis (TEN) is on the same disease spectrum as SJS, where SJS involved less than 10 per cent of the body, SJS-TEN complex involves 10 to 30 per cent of the body and TEN involves more than 30 per cent of the body PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGFybWE8L0F1dGhvcj48WWVhcj4yMDE2PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (Sharma et al., 2016). Ocular manifestations occur in 50 to 80 per cent of patients with SJS or TEN PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGFybWE8L0F1dGhvcj48WWVhcj4yMDE2PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (Hsu et al., 2012, Wander and Kroger, 2020):Mild/moderate: less than 1/3 lid margin involvement, conjunctival defects less than 1 cm and no corneal epithelial defectsSevere: greater than 1/3 lid margin involvement, conjunctival defects greater than 1 cm or presence of corneal epithelial defects.For both mild/moderate and severe cases standard ophthalmic care involves an ophthalmic examination within 24 hours, supportive treatment with topical antibiotics, cyclosporin twice daily and topical steroids 4-8 times per day PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Ic3U8L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFyPjxSZWNO
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ADDIN EN.CITE.DATA (Hsu et al., 2012, Sharma et al., 2016, Slentz and Hemmati, 2013, Wander and Kroger, 2020). Expert advice is that patients would be treated as in-patients and require daily follow-up until the systemic disease is being well managed and corneal healing has occurred ADDIN EN.CITE <EndNote><Cite><Author>Associate Professor of Ophthalmology</Author><Year>2020</Year><RecNum>1</RecNum><DisplayText>(Associate Professor of Ophthalmology, 2020)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584333988">1</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Associate Professor of Ophthalmology,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by an Associate Professor of Ophthalmology, phone call, 27 February 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(Associate Professor of Ophthalmology, 2020). Amnion membrane has been suggested as an adjunct to supportive care in the acute phase of SJS for both mild/moderate and severe forms of the disease PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGFybWE8L0F1dGhvcj48WWVhcj4yMDE2PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (Sharma et al., 2016). Other authors have suggested amnion is more appropriately used as an adjunct for severe cases ADDIN EN.CITE <EndNote><Cite><Author>Slentz</Author><Year>2013</Year><RecNum>8</RecNum><DisplayText>(Slentz and Hemmati, 2013, Wander and Kroger, 2020)</DisplayText><record><rec-number>8</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584335048">8</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Slentz, D.</author><author>Hemmati, H.</author></authors></contributors><titles><title>Management of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis</title></titles><volume>2020</volume><number>16 March</number><dates><year>2013</year></dates><publisher>American Academy of Ophthalmology</publisher><urls><related-urls><url> app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584335321">11</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Wander, A.</author><author>Kroger, J.</author></authors></contributors><titles><title>Stevens-Johnson Syndrome</title></titles><volume>2020</volume><number>16 March</number><dates><year>2020</year></dates><publisher>American Academy of Ophthalmology</publisher><urls><related-urls><url>;(Slentz and Hemmati, 2013, Wander and Kroger, 2020).SJS and TEN are rare conditions, a 10-year retrospective review of all SJS and TEN cases diagnosed at a tertiary referral centre in New South Wales between 2006 and 2016 identified 42 patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DaGFuPC9BdXRob3I+PFllYXI+MjAxOTwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA (Chan and Cook, 2019). Similarly, a retrospective chart review of all cases treated at a tertiary hospital in South Australia between 2000 and 2017 identified 42 patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UcmFuPC9BdXRob3I+PFllYXI+MjAxOTwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA (Tran and Sidhu, 2019).PASC advised that the submission should consider whether there is sufficient evidence to support amnion membrane use for all patients with SJS or only a subgroup of patients with more severe disease.PterygiumPterygium is a fibrovascular growth of the bulbar conjunctiva that can extend over the cornea and cause irritation and impair vision ADDIN EN.CITE <EndNote><Cite><Author>Noureddin</Author><Year>2016</Year><RecNum>14</RecNum><DisplayText>(Noureddin and Yeung, 2016)</DisplayText><record><rec-number>14</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584335597">14</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Noureddin, G. S.</author><author>Yeung, S. N.</author></authors></contributors><auth-address>Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, BC, Canada.</auth-address><titles><title>The use of dry amniotic membrane in pterygium surgery</title><secondary-title>Clin Ophthalmol</secondary-title><alt-title>Clinical ophthalmology (Auckland, N.Z.)</alt-title></titles><periodical><full-title>Clin Ophthalmol</full-title><abbr-1>Clinical ophthalmology (Auckland, N.Z.)</abbr-1></periodical><alt-periodical><full-title>Clin Ophthalmol</full-title><abbr-1>Clinical ophthalmology (Auckland, N.Z.)</abbr-1></alt-periodical><pages>705-12</pages><volume>10</volume><edition>2016/05/05</edition><keywords><keyword>amniotic membrane</keyword><keyword>conjunctival autograft</keyword><keyword>cornea</keyword><keyword>pterygium</keyword></keywords><dates><year>2016</year></dates><isbn>1177-5467 (Print)
1177-5467</isbn><accession-num>27143848</accession-num><urls></urls><custom2>PMC4841395</custom2><electronic-resource-num>10.2147/opth.S80102</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>(Noureddin and Yeung, 2016). Risk factors for pterygium include sunlight exposure, dusty or sandy environment and increasing age ADDIN EN.CITE <EndNote><Cite><Author>BetterHealth</Author><Year>2016</Year><RecNum>15</RecNum><DisplayText>(BetterHealth, 2016)</DisplayText><record><rec-number>15</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584335691">15</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>BetterHealth,</author></authors></contributors><titles><title>Pterygium</title></titles><volume>2020</volume><number>16 March</number><dates><year>2016</year></dates><publisher>Victoria State Government</publisher><urls><related-urls><url>;(BetterHealth, 2016).Minor cases, where the principle issue is symptoms control (for irritation, mild pain and itching), can be treated with supportive care including eye drops or ointments to provide lubrication to the eye and reduce inflammation. If growth is significant such that discomfort is marked and/or vision is impaired then surgery involving conjunctiva autografting can be performed ADDIN EN.CITE <EndNote><Cite><Author>VEI</Author><Year>2020</Year><RecNum>16</RecNum><DisplayText>(VEI, 2020)</DisplayText><record><rec-number>16</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584335762">16</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>VEI,</author></authors></contributors><titles><title>Pterygium</title></titles><volume>2020</volume><number>16 March</number><dates><year>2020</year></dates><publisher>Vision Eye Institute</publisher><urls></urls></record></Cite></EndNote>(VEI, 2020).Conjunctival autografting involves excision of the pterygium and using the patient’s own grafted conjunctiva to close the remaining defect ADDIN EN.CITE <EndNote><Cite><Author>Noureddin</Author><Year>2016</Year><RecNum>14</RecNum><DisplayText>(Noureddin and Yeung, 2016)</DisplayText><record><rec-number>14</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584335597">14</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Noureddin, G. S.</author><author>Yeung, S. N.</author></authors></contributors><auth-address>Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, BC, Canada.</auth-address><titles><title>The use of dry amniotic membrane in pterygium surgery</title><secondary-title>Clin Ophthalmol</secondary-title><alt-title>Clinical ophthalmology (Auckland, N.Z.)</alt-title></titles><periodical><full-title>Clin Ophthalmol</full-title><abbr-1>Clinical ophthalmology (Auckland, N.Z.)</abbr-1></periodical><alt-periodical><full-title>Clin Ophthalmol</full-title><abbr-1>Clinical ophthalmology (Auckland, N.Z.)</abbr-1></alt-periodical><pages>705-12</pages><volume>10</volume><edition>2016/05/05</edition><keywords><keyword>amniotic membrane</keyword><keyword>conjunctival autograft</keyword><keyword>cornea</keyword><keyword>pterygium</keyword></keywords><dates><year>2016</year></dates><isbn>1177-5467 (Print)
1177-5467</isbn><accession-num>27143848</accession-num><urls></urls><custom2>PMC4841395</custom2><electronic-resource-num>10.2147/opth.S80102</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>(Noureddin and Yeung, 2016).AIHW data from 2017/18 shows 9,013 excision of pterygium procedures were performed in Australia ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2019</Year><RecNum>17</RecNum><DisplayText>(AIHW, 2019)</DisplayText><record><rec-number>17</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584335881">17</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW,</author></authors></contributors><titles><title>Procedures Data Cubes, Procedures and healthcare interventions (ACHI 10th edition), Australia, 2017-18</title></titles><volume>2020</volume><number>16 March</number><dates><year>2019</year></dates><publisher>Australian Institute of Health and Welfare</publisher><urls><related-urls><url>;(AIHW, 2019). It is not known what level of severity these procedures represent; therefore, the number of patients potentially eligible for amnion membrane in this subpopulation is not known.Other ophthalmic conditionsAmnion membrane may also be indicated for other types of surgery where the cornea is removed, for example ocular surface squama neoplasia removal. Sufficient cornea should be removed such that all involved tissue is removed as well as a clear margin of unaffected cells ADDIN EN.CITE <EndNote><Cite><Author>Bunya</Author><Year>2019</Year><RecNum>18</RecNum><DisplayText>(Bunya and Chang, 2019)</DisplayText><record><rec-number>18</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584335968">18</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Bunya, V.</author><author>Chang, V.</author></authors></contributors><titles><title>Ocular Surface Squamous neoplasia</title></titles><volume>2020</volume><number>16 March</number><dates><year>2019</year></dates><publisher>American Academy of Ophthalmology</publisher><urls><related-urls><url>;(Bunya and Chang, 2019). Expert advice is that post-surgery of this type, standard supportive care includes use of an eye patch, prophylactic antibiotics, topical steroids, topical cycloplegic agents and oral pain relief as required ADDIN EN.CITE <EndNote><Cite><Author>Associate Professor of Ophthalmology</Author><Year>2020</Year><RecNum>1</RecNum><DisplayText>(Associate Professor of Ophthalmology, 2020)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584333988">1</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Associate Professor of Ophthalmology,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by an Associate Professor of Ophthalmology, phone call, 27 February 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(Associate Professor of Ophthalmology, 2020).Recent data suggest amnion membrane may not be as effective as conjunctival autografting except where large or double headed or where conjunctiva cannot be harvested ADDIN EN.CITE <EndNote><Cite><Author>Noureddin</Author><Year>2016</Year><RecNum>14</RecNum><DisplayText>(Noureddin and Yeung, 2016)</DisplayText><record><rec-number>14</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584335597">14</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Noureddin, G. S.</author><author>Yeung, S. N.</author></authors></contributors><auth-address>Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, BC, Canada.</auth-address><titles><title>The use of dry amniotic membrane in pterygium surgery</title><secondary-title>Clin Ophthalmol</secondary-title><alt-title>Clinical ophthalmology (Auckland, N.Z.)</alt-title></titles><periodical><full-title>Clin Ophthalmol</full-title><abbr-1>Clinical ophthalmology (Auckland, N.Z.)</abbr-1></periodical><alt-periodical><full-title>Clin Ophthalmol</full-title><abbr-1>Clinical ophthalmology (Auckland, N.Z.)</abbr-1></alt-periodical><pages>705-12</pages><volume>10</volume><edition>2016/05/05</edition><keywords><keyword>amniotic membrane</keyword><keyword>conjunctival autograft</keyword><keyword>cornea</keyword><keyword>pterygium</keyword></keywords><dates><year>2016</year></dates><isbn>1177-5467 (Print)
1177-5467</isbn><accession-num>27143848</accession-num><urls></urls><custom2>PMC4841395</custom2><electronic-resource-num>10.2147/opth.S80102</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>(Noureddin and Yeung, 2016). This is consistent with expert advice that generally, when portions of the cornea are surgically removed, supportive care is enough for healing in most cases except those where extensive corneal removal is required ADDIN EN.CITE <EndNote><Cite><Author>Associate Professor of Ophthalmology</Author><Year>2020</Year><RecNum>1</RecNum><DisplayText>(Associate Professor of Ophthalmology, 2020)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584333988">1</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Associate Professor of Ophthalmology,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by an Associate Professor of Ophthalmology, phone call, 27 February 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(Associate Professor of Ophthalmology, 2020). PASC advised that the submission should consider whether amnion membrane is indicated for all patients undergoing surgical corneal removal or only a subgroup of patients undergoing extensive removal.Chronic ophthalmic woundsIn addition to conditions listed above, the Applicant stated that amnion membrane is also suitable for any ophthalmic wound which is refractory to healing. Corneal wounds may become chronic wounds due to epithelial or stem cell deficiency, presence of inflammatory disease (e.g. due to keratoconjunctivitis sicca), neurotrophic disease (for example due to diabetes or nerve damage from ocular surgery) or due to mechanical factors, such as abnormal lid pathology, which can lead to epithelial trauma and stem cell attrition . ADDIN EN.CITE <EndNote><Cite><Author>Gupta</Author><Year>2014</Year><RecNum>20</RecNum><DisplayText>(Gupta et al., 2014)</DisplayText><record><rec-number>20</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584336166">20</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Gupta, S.</author><author>Gupta, P.</author><author>Sayegh, R.</author></authors></contributors><titles><title>Healing a persistent corneal epithelial defect</title></titles><volume>2020</volume><number>16 March</number><dates><year>2014</year></dates><publisher>American Academy of Ophthalogy</publisher><urls><related-urls><url>;(Gupta et al., 2014). Expert advice is that corneal healing would be expected to be observed within the first month of treatment; failure to heal in this timeframe may indicate amnion treatment is appropriate ADDIN EN.CITE <EndNote><Cite><Author>Associate Professor of Ophthalmology</Author><Year>2020</Year><RecNum>1</RecNum><DisplayText>(Associate Professor of Ophthalmology, 2020)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584333988">1</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Associate Professor of Ophthalmology,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by an Associate Professor of Ophthalmology, phone call, 27 February 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(Associate Professor of Ophthalmology, 2020). These wounds would be treated with standard supportive measures including topical steroids, lubrication and oral tetracyclines ADDIN EN.CITE <EndNote><Cite><Author>Gupta</Author><Year>2014</Year><RecNum>20</RecNum><DisplayText>(Gupta et al., 2014)</DisplayText><record><rec-number>20</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584336166">20</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Gupta, S.</author><author>Gupta, P.</author><author>Sayegh, R.</author></authors></contributors><titles><title>Healing a persistent corneal epithelial defect</title></titles><volume>2020</volume><number>16 March</number><dates><year>2014</year></dates><publisher>American Academy of Ophthalogy</publisher><urls><related-urls><url>;(Gupta et al., 2014).Population 2: Chronic skin woundsFor this Application, chronic wounds are defined as those that have been unresponsive to treatment following at least 12 weeks of standard wound care. PASC noted that the draft PICO proposed the use of amnion membrane in chronic skin wounds defined as unresponsive to treatment for at least 6 weeks. PASC considered that a chronic skin wound is more appropriately defined as a wound that is refractory to treatment after 12 weeks of initial therapy. PASC also considered 12 weeks of standard therapy appropriate before commencing treatment venous ulcers with amnion membrane. PASC considered whether amnion membrane is suitable for patients with deep wounds where bone or tendon are exposed. PASC advised the potential use of amnion membrane as a bridge to appropriate treatment in these patients requires expert advice and consideration of whether evidence is available to demonstrate this is an appropriate treatment (i.e. safe and effective) during the evaluation phase.Chronic skin wounds represent a considerable health and economic burden in Australia, with more than 400,000 Australians affected and health-care related costs in excess of $3.5 billion (2% national health expenditure) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NY0Nvc2tlcjwvQXV0aG9yPjxZZWFyPjIwMTk8L1llYXI+
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ADDIN EN.CITE.DATA (McCosker et al., 2019, Sussman, 2014).The underlying aetiology of the wound is a key determinant of management, for this Application, wounds have been classified as ADDIN EN.CITE <EndNote><Cite><Author>Professor of Vascular Surgery</Author><Year>2020</Year><RecNum>2</RecNum><DisplayText>(Professor of Vascular Surgery, 2020, Sussman, 2014)</DisplayText><record><rec-number>2</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334080">2</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Professor of Vascular Surgery,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by a Professor of Vascular Surgery, email received 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite><Cite><Author>Sussman</Author><Year>2014</Year><RecNum>23</RecNum><record><rec-number>23</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584336640">23</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Sussman, G.</author></authors></contributors><titles><title>Ulcer dressings and management</title><secondary-title>Australian Family Physician</secondary-title></titles><periodical><full-title>Australian Family Physician</full-title></periodical><pages>588-592</pages><volume>43</volume><number>9</number><dates><year>2014</year></dates><urls></urls></record></Cite></EndNote>(Professor of Vascular Surgery, 2020, Sussman, 2014):Venous insufficiency ulcersArterial insufficiency ulcersDiabetic foot ulcers.Venous insufficiency ulcersVenous insufficiency ulcers are caused by a reduction in venous circulation in the lower limbs, which prohibits usual circulation of blood through the leg veins. The resulting increased venous pressure leads to pitting oedema; when an injury occurs, there is insufficient blood supply for healing to occur and an ulcer results ADDIN EN.CITE <EndNote><Cite><Author>Sussman</Author><Year>2014</Year><RecNum>23</RecNum><DisplayText>(Sussman, 2014)</DisplayText><record><rec-number>23</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584336640">23</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Sussman, G.</author></authors></contributors><titles><title>Ulcer dressings and management</title><secondary-title>Australian Family Physician</secondary-title></titles><periodical><full-title>Australian Family Physician</full-title></periodical><pages>588-592</pages><volume>43</volume><number>9</number><dates><year>2014</year></dates><urls></urls></record></Cite></EndNote>(Sussman, 2014). Risk factors for this type of wound includes obesity, prior deep vein thrombosis and poor mobility ADDIN EN.CITE <EndNote><Cite><Author>Sussman</Author><Year>2014</Year><RecNum>23</RecNum><DisplayText>(Sussman, 2014)</DisplayText><record><rec-number>23</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584336640">23</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Sussman, G.</author></authors></contributors><titles><title>Ulcer dressings and management</title><secondary-title>Australian Family Physician</secondary-title></titles><periodical><full-title>Australian Family Physician</full-title></periodical><pages>588-592</pages><volume>43</volume><number>9</number><dates><year>2014</year></dates><urls></urls></record></Cite></EndNote>(Sussman, 2014). Compression therapy from foot to knee should be employed as well as lower limb exercise and avoidance of long periods of standing PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QbGFzdGljIFN1cmdlb248L0F1dGhvcj48WWVhcj4yMDIw
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ADDIN EN.CITE.DATA (Plastic Surgeon, 2020, Professor of Vascular Surgery, 2020, Sussman, 2014, SIGN, 2010).Venous insufficiency ulcers are estimated to occur in 48,000 Australian annually ADDIN EN.CITE <EndNote><Cite><Author>AusHSI</Author><Year>2017</Year><RecNum>31</RecNum><DisplayText>(AusHSI, 2017)</DisplayText><record><rec-number>31</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584337446">31</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AusHSI</author></authors></contributors><titles><title>Issue Paper: Chronic Wounds</title></titles><volume>2018</volume><number>6 November</number><dates><year>2017</year></dates><publisher>Australian Centre For Health Services Innovation </publisher><urls><related-urls><url>;(AusHSI, 2017). Healing rates from standard care range from 30-60% with 24 weeks of treatment and 70-85% with one year of treatment ADDIN EN.CITE <EndNote><Cite><Author>Margolis</Author><Year>1999</Year><RecNum>29</RecNum><DisplayText>(Margolis et al., 1999)</DisplayText><record><rec-number>29</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584337316">29</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Margolis, D. J.</author><author>Berlin, J. A.</author><author>Strom, B. L.</author></authors></contributors><auth-address>Department of Dermatology, Center for Clinical Epidemiology, and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia 19104, USA. dmargoli@cceb.med.upenn.edu</auth-address><titles><title>Risk factors associated with the failure of a venous leg ulcer to heal</title><secondary-title>Arch Dermatol</secondary-title><alt-title>Archives of dermatology</alt-title></titles><periodical><full-title>Arch Dermatol</full-title><abbr-1>Archives of dermatology</abbr-1></periodical><alt-periodical><full-title>Arch Dermatol</full-title><abbr-1>Archives of dermatology</abbr-1></alt-periodical><pages>920-6</pages><volume>135</volume><number>8</number><edition>1999/08/24</edition><keywords><keyword>Aged</keyword><keyword>*Bandages</keyword><keyword>Cohort Studies</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Leg Ulcer/*therapy</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Retrospective Studies</keyword><keyword>Risk Factors</keyword><keyword>Treatment Failure</keyword><keyword>Wound Healing</keyword></keywords><dates><year>1999</year><pub-dates><date>Aug</date></pub-dates></dates><isbn>0003-987X (Print)
0003-987x</isbn><accession-num>10456340</accession-num><urls></urls><electronic-resource-num>10.1001/archderm.135.8.920</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>(Margolis et al., 1999).Arterial insufficiency ulcersArterial insufficiency ulcers typically present on the ankle and foot and are associated with ischemic pain. Risk factors of arterial insufficiency ulcers are poorly controlled diabetes and smoking. These ulcers should be assessed for surgery to address revascularisation, adequate pain management should be provided and should not be treated with compression therapy ADDIN EN.CITE <EndNote><Cite><Author>Plastic Surgeon</Author><Year>2020</Year><RecNum>3</RecNum><DisplayText>(Plastic Surgeon, 2020, Professor of Vascular Surgery, 2020, Sussman, 2014)</DisplayText><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334150">3</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Plastic Surgeon,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by a Plastic, Reconstructive and Hand Surgeon, email 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite><Cite><Author>Professor of Vascular Surgery</Author><Year>2020</Year><RecNum>2</RecNum><record><rec-number>2</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334080">2</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Professor of Vascular Surgery,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by a Professor of Vascular Surgery, email received 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite><Cite><Author>Sussman</Author><Year>2014</Year><RecNum>23</RecNum><record><rec-number>23</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584336640">23</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Sussman, G.</author></authors></contributors><titles><title>Ulcer dressings and management</title><secondary-title>Australian Family Physician</secondary-title></titles><periodical><full-title>Australian Family Physician</full-title></periodical><pages>588-592</pages><volume>43</volume><number>9</number><dates><year>2014</year></dates><urls></urls></record></Cite></EndNote>(Plastic Surgeon, 2020, Professor of Vascular Surgery, 2020, Sussman, 2014).No population prevalence data for arterial insufficiency ulcers was identified; it is estimated that these types of wound make up 3-19% of lower extremity ulcers, 1-11% of all types of wound (including chronic, surgical and traumatic) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NY0Nvc2tlcjwvQXV0aG9yPjxZZWFyPjIwMTk8L1llYXI+
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ADDIN EN.CITE.DATA (McCosker et al., 2019). Specifically considering chronic skin wounds, arterial insufficiency ulcers are estimated to comprise 1% of the total (estimated as being 400,000) ADDIN EN.CITE <EndNote><Cite><Author>AusHSI</Author><Year>2017</Year><RecNum>31</RecNum><DisplayText>(AusHSI, 2017)</DisplayText><record><rec-number>31</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584337446">31</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AusHSI</author></authors></contributors><titles><title>Issue Paper: Chronic Wounds</title></titles><volume>2018</volume><number>6 November</number><dates><year>2017</year></dates><publisher>Australian Centre For Health Services Innovation </publisher><urls><related-urls><url>;(AusHSI, 2017). This would give an estimated 4,000 chronic arterial ulcers annually.Diabetic foot ulcersDiabetes mellitus causes nerve damage (neuropathy) in the feet and lower limbs resulting in reduced or loss of sensation which may lead to injuries being unnoticed and progressing to a more advanced stage before being treated PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BbGF2aTwvQXV0aG9yPjxZZWFyPjIwMTQ8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (McCosker et al., 2019). Initial management should include addressing overall diabetes management, offloading and surgery for revascularisation if relevant). In addition to the above wound-specific management, all wounds should be debrided, treated for infection if present and nutritional factors (such as vitamin deficiency) should be addressed ADDIN EN.CITE <EndNote><Cite><Author>Professor of Vascular Surgery</Author><Year>2020</Year><RecNum>2</RecNum><DisplayText>(Professor of Vascular Surgery, 2020, Plastic Surgeon, 2020)</DisplayText><record><rec-number>2</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334080">2</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Professor of Vascular Surgery,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by a Professor of Vascular Surgery, email received 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite><Cite><Author>Plastic Surgeon</Author><Year>2020</Year><RecNum>3</RecNum><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334150">3</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Plastic Surgeon,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by a Plastic, Reconstructive and Hand Surgeon, email 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(Professor of Vascular Surgery, 2020, Plastic Surgeon, 2020).Wounds should be dressed to obtain the optimum moist environment for wound healing. Expert advice is that a range of first-line dressings are used routinely in Australia including alginate, film, foam, hydrocolloid and hydrogel dressings ADDIN EN.CITE <EndNote><Cite><Author>Professor of Vascular Surgery</Author><Year>2020</Year><RecNum>2</RecNum><DisplayText>(Professor of Vascular Surgery, 2020)</DisplayText><record><rec-number>2</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334080">2</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Professor of Vascular Surgery,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by a Professor of Vascular Surgery, email received 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(Professor of Vascular Surgery, 2020). The optimum dressing for each patient will also depend on wound type, depth, level of exudate, patient comfort and costs ADDIN EN.CITE <EndNote><Cite><Author>IWGDF</Author><Year>2019</Year><RecNum>27</RecNum><DisplayText>(IWGDF, 2019, Sussman, 2014)</DisplayText><record><rec-number>27</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584337155">27</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>IWGDF,</author></authors></contributors><titles><title>IWGDF Practical guidelines on the prevention and management of diabetic foot disease</title></titles><volume>2020</volume><number>16 March</number><dates><year>2019</year></dates><publisher>International Working Group on the Diabetic Foot </publisher><urls><related-urls><url> app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584336640">23</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Sussman, G.</author></authors></contributors><titles><title>Ulcer dressings and management</title><secondary-title>Australian Family Physician</secondary-title></titles><periodical><full-title>Australian Family Physician</full-title></periodical><pages>588-592</pages><volume>43</volume><number>9</number><dates><year>2014</year></dates><urls></urls></record></Cite></EndNote>(IWGDF, 2019, Sussman, 2014).It is estimated that 7-17% of diabetic foot ulcers fail to heal after initial treatment and would therefore be considered chronic. This estimate is based on an estimated 1.7 million Australians having diabetes, 4-10% of these patients developing an ulcer and reported data that approximately 3% of the 400,000 estimated chronic skin wounds in Australia are diabetic foot ulcers PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BbGV4aWFkb3U8L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFy
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ADDIN EN.CITE.DATA (Alexiadou and Doupis, 2012, Diabetes Australia, 2020, AusHSI, 2017). Advice from the Department of Health Medical Advisor is that this estimate is reasonable ADDIN EN.CITE <EndNote><Cite><Author>Advisor</Author><Year>2020</Year><RecNum>28</RecNum><DisplayText>(DoH Medical Advisor, 2020a)</DisplayText><record><rec-number>28</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584337247">28</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>DoH Medical Advisor,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication from DoH Medical Advisor, email recieved 11 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(DoH Medical Advisor, 2020a). This would give an upper limit of 12,000 patients annually for this part of the proposed population.Population 3: Patients with acute wounds (i.e. burns where patients require a dermal substitute before skin grafting can take place); and (and added since receipt of the Application) treatment of graft site; or skin graft fixator and toxic epidermal necrolysisPASC noted that Population 3 defined patients with acute wounds, including patients with burns that require a dermal substitute before skin grafting and that the applicant had proposed three additional sub-populations: patients who require treatment of a skin graft donor site; patients who require a skin graft fixator and patients with toxic epidermal necrolysis. The Summary PICO was updated to reflect these three subpopulations.Burns where patients require a dermal substitute before skin grafting can take placeManagement of burns in Australia involves emergency response, transfer to hospital and assessment. Treatment post-presentation to emergency depends on the severity of the burn. Minor burns may be managed in an outpatient setting and are expected to heal in 10-14 days. More serious burns require referral to specialist burns units. Referral criteria are ADDIN EN.CITE <EndNote><Cite><Author>BRANZ</Author><Year>2019</Year><RecNum>30</RecNum><DisplayText>(BRANZ, 2019)</DisplayText><record><rec-number>30</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584337404">30</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>BRANZ,</author></authors></contributors><titles><title>Annual Report 1 July 2017 - 30 June 2018</title></titles><volume>2020</volume><number>16 March</number><dates><year>2019</year></dates><publisher>Burns Registry of Australia and New Zealand</publisher><urls><related-urls><url>;(BRANZ, 2019):burns greater than 10 per cent of total body surface area; burns of special areas—face, hands, feet, genitalia, perineum, and major joints; full-thickness burns greater than five per cent of TBSA; electrical burns; chemical burns; burns with an associated inhalation injury; circumferential burns of the limbs or chest; burns in the very young or very old, or pregnant; burns in people with pre-existing medical disorders that could complicate management, prolong recovery, or increase mortality; burns with associated trauma; and non-accidental burns Debridement and split skin grafting are recommended for all full thickness burns and most non-superficial partial thickness burns. Expert advice is that dermal substitutes such as amnion membrane do not replace skin grafts under current Australian management of burns. Instead these products are used as a bridge to skin grafts in patients where immediate skin grafting is not possible or where additional support is required for the skin graft. This may include the following sub-populations ADDIN EN.CITE <EndNote><Cite><Author>Plastic and Reconstructive Surgeon</Author><Year>2018</Year><RecNum>4</RecNum><DisplayText>(Plastic and Reconstructive Surgeon, 2018, Plastic Surgeon, 2020)</DisplayText><record><rec-number>4</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334365">4</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Plastic and Reconstructive Surgeon,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication received from a Plastic and Reconstructive Surgeon, phonecall, 16 October 2018</title></titles><dates><year>2018</year></dates><urls></urls></record></Cite><Cite><Author>Plastic Surgeon</Author><Year>2020</Year><RecNum>3</RecNum><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334150">3</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Plastic Surgeon,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by a Plastic, Reconstructive and Hand Surgeon, email 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(Plastic and Reconstructive Surgeon, 2018, Plastic Surgeon, 2020):Patients with a burn requiring a skin graft where the patient is not able to undergo immediate grafting (due to large burn surface area or who require stabilisation)Patients with a burn in a priority area (for example the face, hands, feet, genitalia) where a dermal substitute is required for cosmetic outcomesPatients for whom skin contracture may be problematic Where radiotherapy is anticipated post-operatively.Data on the number of procedures from the Burns Registry of Australia and New Zealand (BRANZ) for the 2017/18 financial year is reported in REF _Ref35267913 \h Table 1. A total of 1658 skin graft procedures were performed ADDIN EN.CITE <EndNote><Cite><Author>BRANZ</Author><Year>2019</Year><RecNum>30</RecNum><DisplayText>(BRANZ, 2019)</DisplayText><record><rec-number>30</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584337404">30</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>BRANZ,</author></authors></contributors><titles><title>Annual Report 1 July 2017 - 30 June 2018</title></titles><volume>2020</volume><number>16 March</number><dates><year>2019</year></dates><publisher>Burns Registry of Australia and New Zealand</publisher><urls><related-urls><url>;(BRANZ, 2019). This would be the maximum potential utilisation of amnion membrane in this population. However, expert advice is that most patients do not require a dermal substitute prior to skin grafting; therefore, expected utilisation of amnion membrane, if adopted into clinical practice, would be much lower (less than 5-10% of total skin graft patients). This is reflected in the utilisation figures shown in REF _Ref35267913 \h Table 1; where only 1% of adult patients required Integra (a comparator to amnion membrane in this population; see Comparator section).Table SEQ Table \* ARABIC 1Burns procedures, 2017-2018ProcedurePaediatric patients n (%)Adult patients n (%)Debridement and skin grafting336 (46%)1322 (59%)Debridement and temporary skin closure product e.g. BiobraneTM 93 (13%)319 (14%)Debridement and skin cell product73 (10%)200 (9%)Debridement only224 (31%)371 (17%)Debridement and reconstructive product eg IntegraTM2 (0%)12 (1%)Debridement and temporary skin closure with cadaver skin5 (1%)43 (2%)Source: BRANZ Annual report ADDIN EN.CITE <EndNote><Cite><Author>BRANZ</Author><Year>2019</Year><RecNum>30</RecNum><DisplayText>(BRANZ, 2019)</DisplayText><record><rec-number>30</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584337404">30</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>BRANZ,</author></authors></contributors><titles><title>Annual Report 1 July 2017 - 30 June 2018</title></titles><volume>2020</volume><number>16 March</number><dates><year>2019</year></dates><publisher>Burns Registry of Australia and New Zealand</publisher><urls><related-urls><url>;(BRANZ, 2019)Patients with a graft donor site wound Most skin-graft treatments, for example those used for burns, are autografts (see Table 1); either split-skin thickness or full thickness depth may be taken for the graft ADDIN EN.CITE <EndNote><Cite><Author>Romanelli</Author><Year>2019</Year><RecNum>42</RecNum><DisplayText>(Romanelli et al., 2019)</DisplayText><record><rec-number>42</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584917809">42</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Romanelli, M.</author><author>Serena, T.</author><author>Kimble, R.</author><author>Han, S.</author><author>Kim, J.</author><author>Cruz, J.</author><author>Chong, S.</author><author>AL Assar, M.</author></authors></contributors><titles><title>Skin graft donor site management in the treatment of burns and hard-to-heal wounds</title></titles><volume>2020</volume><number>23 March</number><dates><year>2019</year></dates><publisher>Wounds International</publisher><urls><related-urls><url>;(Romanelli et al., 2019). Therefore, as well as treating the burn or wound, the graft site also represents an acute wound which must be managed. Amnion membrane has been investigated as a treatment for these wounds PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BYnVsPC9BdXRob3I+PFllYXI+MjAyMDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA (Abul et al., 2020, Eskandarlou et al., 2016). Primary dressing type is selected dependent on many factors including wear time, exudate management, adhesiveness, infection control patient comfort, pain, odour control, cost and ensuring an optimum wound healing environment ADDIN EN.CITE <EndNote><Cite><Author>Romanelli</Author><Year>2019</Year><RecNum>42</RecNum><DisplayText>(Romanelli et al., 2019)</DisplayText><record><rec-number>42</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584917809">42</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Romanelli, M.</author><author>Serena, T.</author><author>Kimble, R.</author><author>Han, S.</author><author>Kim, J.</author><author>Cruz, J.</author><author>Chong, S.</author><author>AL Assar, M.</author></authors></contributors><titles><title>Skin graft donor site management in the treatment of burns and hard-to-heal wounds</title></titles><volume>2020</volume><number>23 March</number><dates><year>2019</year></dates><publisher>Wounds International</publisher><urls><related-urls><url>;(Romanelli et al., 2019). Wound healing is expected in 10 to 21 days depending on the depth and area of skin removed ADDIN EN.CITE <EndNote><Cite><Author>Romanelli</Author><Year>2019</Year><RecNum>42</RecNum><DisplayText>(Romanelli et al., 2019, VABS, 2019b)</DisplayText><record><rec-number>42</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584917809">42</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Romanelli, M.</author><author>Serena, T.</author><author>Kimble, R.</author><author>Han, S.</author><author>Kim, J.</author><author>Cruz, J.</author><author>Chong, S.</author><author>AL Assar, M.</author></authors></contributors><titles><title>Skin graft donor site management in the treatment of burns and hard-to-heal wounds</title></titles><volume>2020</volume><number>23 March</number><dates><year>2019</year></dates><publisher>Wounds International</publisher><urls><related-urls><url> app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584918008">43</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>VABS,</author></authors></contributors><titles><title>Donor Site Management</title></titles><volume>2020</volume><number>23 March</number><dates><year>2019</year></dates><publisher>Victorian Adult Burns Service At The Alfred</publisher><urls><related-urls><url>;(Romanelli et al., 2019, VABS, 2019b). For some patients, healing may be delayed due to age, comorbidities (diabetes, cardiovascular issues, renal insufficiency), smoking and poor nutritional status ADDIN EN.CITE <EndNote><Cite><Author>Romanelli</Author><Year>2019</Year><RecNum>42</RecNum><DisplayText>(Romanelli et al., 2019)</DisplayText><record><rec-number>42</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584917809">42</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Romanelli, M.</author><author>Serena, T.</author><author>Kimble, R.</author><author>Han, S.</author><author>Kim, J.</author><author>Cruz, J.</author><author>Chong, S.</author><author>AL Assar, M.</author></authors></contributors><titles><title>Skin graft donor site management in the treatment of burns and hard-to-heal wounds</title></titles><volume>2020</volume><number>23 March</number><dates><year>2019</year></dates><publisher>Wounds International</publisher><urls><related-urls><url>;(Romanelli et al., 2019). Ensuring adequate vascularisation for healing at the graft donor site is also an important factor in wound healing ADDIN EN.CITE <EndNote><Cite><Author>Romanelli</Author><Year>2019</Year><RecNum>42</RecNum><DisplayText>(Romanelli et al., 2019)</DisplayText><record><rec-number>42</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584917809">42</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Romanelli, M.</author><author>Serena, T.</author><author>Kimble, R.</author><author>Han, S.</author><author>Kim, J.</author><author>Cruz, J.</author><author>Chong, S.</author><author>AL Assar, M.</author></authors></contributors><titles><title>Skin graft donor site management in the treatment of burns and hard-to-heal wounds</title></titles><volume>2020</volume><number>23 March</number><dates><year>2019</year></dates><publisher>Wounds International</publisher><urls><related-urls><url>;(Romanelli et al., 2019).PASC noted the assessment group is still awaiting expert advice on whether it is appropriate to consider use of amnion membrane in all patients with a graft-donor site wound, or whether it should be limited to patients for whom healing is expected (or observed to be) delayed (e.g. due to underlying patient co-morbidity).The assessment group noted that advice on this matter was not received in time for the development of this PICO and as such, it is suggested the submission goes on to assess what evidence is available for this population and clarify this issue with an expert in this area during the evaluation phase. Patients requiring skin graft fixatorsSkin graft adherence to the wound bed is critical to ensure the graft revascularizes and the wound heals ADDIN EN.CITE <EndNote><Cite><Author>Thorton</Author><Year>2004</Year><RecNum>44</RecNum><DisplayText>(Thorton and Gosman, 2004)</DisplayText><record><rec-number>44</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584918633">44</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Thorton, J.</author><author>Gosman, A.</author></authors></contributors><titles><title>Skin grafts, skin subsitutes and principles of flaps</title></titles><volume>2020</volume><number>23 March</number><dates><year>2004</year></dates><publisher>Selected Readings in Plastic Surgery</publisher><urls><related-urls><url>;(Thorton and Gosman, 2004). 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ADDIN EN.CITE.DATA (Mohammadi et al., 2013, Kamolz et al., 2014, Ramos, 2007). Recent literature has investigated amnion membrane as a skin graft fixator, replacing other graft fixation techniques PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb2hhbW1hZGk8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFy
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ADDIN EN.CITE.DATA (Mohammadi et al., 2013).It is not known how many patients undergoing a skin graft may be eligible for amnion fixation.Patients with toxic epidermal necrolysis skin lesions requiring dressingAs described above for Population 1, TEN is characterised by blistering and necrosis which can be life threatening. Patients with TEN are usually treated in an intensive care and burns unit ADDIN EN.CITE <EndNote><Cite><Author>Ngan</Author><Year>2016</Year><RecNum>50</RecNum><DisplayText>(Ngan et al., 2016)</DisplayText><record><rec-number>50</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584920236">50</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Ngan, V.</author><author>Oakley, A.</author><author>Dyall-Smith, D.</author></authors></contributors><titles><title>Stevens–Johnson syndrome / toxic epidermal necrolysis</title></titles><volume>2020</volume><number>23 March</number><dates><year>2016</year></dates><publisher>DermNetNZ</publisher><urls><related-urls><url>;(Ngan et al., 2016). Standard care for skin lesions in TEN and involves leaving and skin blebs and blisters intact to act as a natural dressing PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LbGFtYS1CYXJ5bGE8L0F1dGhvcj48WWVhcj4yMDIwPC9Z
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ADDIN EN.CITE.DATA (Klama-Baryla et al., 2020). Necrotic tissue needs to be removed and wounds dressed; BioBrane is reported as a skin substitute which can be used to dress acute wounds in these patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LbGFtYS1CYXJ5bGE8L0F1dGhvcj48WWVhcj4yMDIwPC9Z
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ADDIN EN.CITE.DATA (Klama-Baryla et al., 2020). The acute phase of TEN lasts from 8 to 12 days, with reepithelization taking several weeks to be complete ADDIN EN.CITE <EndNote><Cite><Author>Ngan</Author><Year>2016</Year><RecNum>50</RecNum><DisplayText>(Ngan et al., 2016)</DisplayText><record><rec-number>50</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584920236">50</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Ngan, V.</author><author>Oakley, A.</author><author>Dyall-Smith, D.</author></authors></contributors><titles><title>Stevens–Johnson syndrome / toxic epidermal necrolysis</title></titles><volume>2020</volume><number>23 March</number><dates><year>2016</year></dates><publisher>DermNetNZ</publisher><urls><related-urls><url>;(Ngan et al., 2016). Amnion membrane as an alternate treatment for these dermatological lesions PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LbGFtYS1CYXJ5bGE8L0F1dGhvcj48WWVhcj4yMDIwPC9Z
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ADDIN EN.CITE.DATA (Klama-Baryla et al., 2020, Klama-Baryla et al., 2018). RationaleThe proposed populations cover a large number of potential patients; however, it is not clear if all patients in the proposed populations could and/or should receive amnion membrane.For Population 1, it may be appropriate to investigate whether there is evidence to support limiting amnion membrane use to patients with moderate/severe forms of the SJS, moderate/severe burns and patients undergoing extensive corneal removal surgery. For Population 2, the two experts advising on this PICO were explicitly asked if the current definition for Population 2 could be further refined to identify and target subpopulations for whom amnion membrane may provide greater benefit or be better targeted. Advice from experts was that the current definition represents patients with ‘difficult to heal’ wounds; however, expert advice noted that amnion membrane is not suitable for patients with deep wounds where bone and/or tendon are exposed ADDIN EN.CITE <EndNote><Cite><Author>DoH identified Expert</Author><Year>2020</Year><RecNum>21</RecNum><DisplayText>(DoH identified Expert, 2020, Plastic Surgeon, 2020)</DisplayText><record><rec-number>21</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584336324">21</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>DoH identified Expert,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Expert advice obtained by the Department of Health from a Plastic Surgeon, email recieved 16 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite><Cite><Author>Plastic Surgeon</Author><Year>2020</Year><RecNum>3</RecNum><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334150">3</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Plastic Surgeon,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by a Plastic, Reconstructive and Hand Surgeon, email 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(DoH identified Expert, 2020, Plastic Surgeon, 2020). No other key subpopulations for inclusion or exclusion were identified by experts.However, for a prior dehydrated amnion membrane application, PASC previously suggested that “one clear subpopulation could be patients with wounds that expose bone or tendon.” PASC addressed the issue during its consideration of Population 2: Chronic skin wounds.For Population 2, there is some discrepancy as to how a “chronic wound” should be defined. Expert advice is that “unresponsive to treatment” would be wounds that have failed to reduce in size by 40-50% during the initial 6 weeks ADDIN EN.CITE <EndNote><Cite><Author>Professor of Vascular Surgery</Author><Year>2020</Year><RecNum>2</RecNum><DisplayText>(Professor of Vascular Surgery, 2020, Plastic Surgeon, 2020)</DisplayText><record><rec-number>2</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334080">2</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Professor of Vascular Surgery,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by a Professor of Vascular Surgery, email received 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite><Cite><Author>Plastic Surgeon</Author><Year>2020</Year><RecNum>3</RecNum><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334150">3</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Plastic Surgeon,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by a Plastic, Reconstructive and Hand Surgeon, email 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(Professor of Vascular Surgery, 2020, Plastic Surgeon, 2020). The Applicant agreed this definition is appropriate. Advice from an expert provided by the Department of Health is that 12 weeks may be a better cut-off, to determine if a wound is “chronic” ADDIN EN.CITE <EndNote><Cite><Author>DoH identified Expert</Author><Year>2020</Year><RecNum>21</RecNum><DisplayText>(DoH identified Expert, 2020)</DisplayText><record><rec-number>21</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584336324">21</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>DoH identified Expert,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Expert advice obtained by the Department of Health from a Plastic Surgeon, email recieved 16 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(DoH identified Expert, 2020). Further, it is noted that, in an amnion membrane application previously considered by PASC, a chronic wound was defined as “failure to show satisfactory healing after > 4 weeks of standard wound care”.PASC addressed the issue during its consideration of Population 2: Chronic skin wounds.After discussion with the Applicant, Population 3 was refined from that proposed (“patients with burns”) to “patients with acute wounds, including: burns where patients require a dermal substitute before skin grafting can take place; treatment of graft site; skin graft fixator; and toxic epidermal necrolysis”. This change was based on expert advice ADDIN EN.CITE <EndNote><Cite><Author>Plastic and Reconstructive Surgeon</Author><Year>2018</Year><RecNum>4</RecNum><DisplayText>(Plastic and Reconstructive Surgeon, 2018, Plastic Surgeon, 2020)</DisplayText><record><rec-number>4</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334365">4</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Plastic and Reconstructive Surgeon,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication received from a Plastic and Reconstructive Surgeon, phonecall, 16 October 2018</title></titles><dates><year>2018</year></dates><urls></urls></record></Cite><Cite><Author>Plastic Surgeon</Author><Year>2020</Year><RecNum>3</RecNum><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334150">3</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Plastic Surgeon,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by a Plastic, Reconstructive and Hand Surgeon, email 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(Plastic and Reconstructive Surgeon, 2018, Plastic Surgeon, 2020), and communication from the Applicant (email received 4 March 2020).InterventionThe proposed intervention is any amnion membrane product. This definition of the intervention differs from that proposed in the Application Form. The Applicant proposed cryopreserved amnion membrane as the intervention for assessment. Following advice from a Department of Health Medical Advisor, this was broadened to include any amnion membrane product, to ensure sufficient evidence was available for the assessment ADDIN EN.CITE <EndNote><Cite><Author>DoH Medical Advisor</Author><Year>2020</Year><RecNum>32</RecNum><DisplayText>(DoH Medical Advisor, 2020b)</DisplayText><record><rec-number>32</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584337882">32</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>DoH Medical Advisor,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication from DoH Medical Advisor, teleconference 18 February 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(DoH Medical Advisor, 2020b). Other amnion membrane products available in Australia are discussed under “Rationale” below.PASC confirmed the proposed intervention as any amnion membrane product.Amnion membrane is purported to promote healing in a variety of ways including (Application Form page 20):providing a scaffold for tissue to regenerate around and providing protection from friction and a moist wound environment;promoting re-epithelisation due to the collagen containing membrane providing a substrate for epithelium cells to grown on;providing an analgesic effect by coving nerve endings;supressing inflammation due to cytokine production and trapping inflammatory cells;inhibiting fibroblast proliferation and differentiation reducing scarring;reducing unwanted vascularisation in the eye by inhibiting blood vessel formation;providing a physical barrier to infection due to antimicrobial properties; and,avoiding immunological rejection due to an absence of HLA antigens.The Applicant described the process for manufacturing cryopreserved amnion membrane in the Application Form (page 21). Cryopreserved amnion membrane is obtained from consenting donors undergoing full-term elective caesarean section births. The donor is assessed in accordance with Therapeutic Goods Order 88. The tissue is treated with antibiotics and antifungals (streptomycin, penicillin and amphotericin). The amnion membrane is then cryopreserved in dimethyl sulfoxide 10% (DMSO), and stored at -80 degrees Celsius. The tissue is quarantined for 3 months before it can be released. Amnion membrane is provided on a nitrocellulose backing paper and is available in three sizes (5 cm diameter circle; 5x10 cm; and 10x10 cm pieces). Following release, the amnion membrane has an expiry of 12 months, if kept frozen. The product is provided with a description of the serological and microbiological status of the graft, and documentation confirming the product is not sterile and therefore may pose a minimal risk to the recipient. Amnion membrane is requested by clinicians wishing to use the product. Requests are processed on a first come/first served basis, with emergency requests given priority. Requests from the private and public health sectors are not differentiated for access. The Applicant noted that the main limit to supply is authorisation of donors.The cryopreserved amnion membrane was listed on the Australian Register of Therapeutic Goods (ARTG) in 2018 ( REF _Ref35268166 \h Table 2).Table SEQ Table \* ARABIC 2ARTG Listing for cryopreserved amnionARTG numberStart dateSponsorCategoryProduct nameProduct typeIntended use30320718/05/2019South Eastern Sydney Local Health DistrictBiological Included Class 2Amniotic membrane, cryopreservedAmnionTreatment of ophthalmic disorder/disease/trauma, or as a wound dressingSource: ARTG Website.For ophthalmic use, the Applicant noted that it likely to occur in an operating theatre, due to the equipment required for ophthalmic procedures. For wounds, amnion may be placed in an operating theatre, following surgical debridement, or in a treatment room, depending on the patient circumstances. The Prostheses List Rules state that items listed on the Prostheses List only attract benefits if used in a hospital or hospital-replacement setting. Advice from experts is that, for Population 1 (ophthalmic conditions), and Population 3 (burns), all patients would be expected to be treated in hospital. For Population 2, expert advice is that the treatment setting would be split between hospital and community settings, but it is reasonable to assume approximately 50% of patients with a ‘difficult to heal’ chronic skin wound would be treated in hospital ADDIN EN.CITE <EndNote><Cite><Author>Plastic Surgeon</Author><Year>2020</Year><RecNum>3</RecNum><DisplayText>(Plastic Surgeon, 2020, Professor of Vascular Surgery, 2020)</DisplayText><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334150">3</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Plastic Surgeon,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by a Plastic, Reconstructive and Hand Surgeon, email 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite><Cite><Author>Professor of Vascular Surgery</Author><Year>2020</Year><RecNum>2</RecNum><record><rec-number>2</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334080">2</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Professor of Vascular Surgery,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by a Professor of Vascular Surgery, email received 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(Plastic Surgeon, 2020, Professor of Vascular Surgery, 2020).PASC confirmed that, as a product listed on the Prostheses List, amnion membrane would be intended for use as treatment in a hospital or hospital substitute setting. PASC requested clarification from the Department about the definition of ‘hospital substitute’, particularly considering the likely use in community settings. Hospital-substitute treatment means general treatment that:substitute for an episode of hospital treatment; andis any of, or any combination of, nursing, medical, surgical, podiatric surgical, diagnostic, therapeutic, prosthetic, pharmacological, pathology or other services or goods intended to manage a disease, injury or condition; andis not specified in the Private Health Insurance (Complying Product) Rules as a treatment that is excluded from this definition.The amnion membrane is absorbed or sloughs off during wound healing, over 7-21 days. If healing is progressing, but not complete, another amnion membrane application may be required (Application Form page 24; and Plastic Surgeon, 2020).The Applicant advised that, since February 2019, there have been 150 requests for cryopreserved amnion membrane product for ophthalmic conditions. The Applicant stated that 150 grafts were released in 2019, to 68 surgeons across Australia (85% in the private sector), for ophthalmic use only.Between 2016 and 2019, cryopreserved amnion membrane was obtained from New Zealand Eye Bank under the Therapeutic Goods Administration (TGA) Special Access Scheme; 157 grafts were obtained for ophthalmic conditions in 2018 (Application Form, page 21).Prior to 2016, cryopreserved amnion membrane was listed on the Australian Human Tissues Prostheses List (billing code LEM03). The Victorian Eye Bank ceased production of amnion membrane due to a decline in usage in Victoria, and due to costs associated with regulatory processes, namely implementation of the TGA Biological Framework (Application Form, page 21). Expert advice is that, while amnion membrane use in Australia for ophthalmic conditions is currently limited, it may increase if a Prostheses Listing was obtained ADDIN EN.CITE <EndNote><Cite><Author>Associate Professor of Ophthalmology</Author><Year>2020</Year><RecNum>1</RecNum><DisplayText>(Associate Professor of Ophthalmology, 2020)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584333988">1</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Associate Professor of Ophthalmology,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by an Associate Professor of Ophthalmology, phone call, 27 February 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(Associate Professor of Ophthalmology, 2020).Expert advice from Plastic and Vascular Surgeons is that amnion membrane products are currently not used in Australia to treat chronic or acute skin wounds ADDIN EN.CITE <EndNote><Cite><Author>Plastic Surgeon</Author><Year>2020</Year><RecNum>3</RecNum><DisplayText>(Plastic Surgeon, 2020, Professor of Vascular Surgery, 2020)</DisplayText><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334150">3</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Plastic Surgeon,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by a Plastic, Reconstructive and Hand Surgeon, email 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite><Cite><Author>Professor of Vascular Surgery</Author><Year>2020</Year><RecNum>2</RecNum><record><rec-number>2</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334080">2</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Professor of Vascular Surgery,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by a Professor of Vascular Surgery, email received 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(Plastic Surgeon, 2020, Professor of Vascular Surgery, 2020). This may change if high-level evidence supporting safety, effectiveness and cost effectiveness is identified, and if the product is eligible for funding. Under those circumstances, it is expected that amnion membrane would be used ADDIN EN.CITE <EndNote><Cite><Author>Plastic Surgeon</Author><Year>2020</Year><RecNum>3</RecNum><DisplayText>(Plastic Surgeon, 2020, Professor of Vascular Surgery, 2020)</DisplayText><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334150">3</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Plastic Surgeon,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by a Plastic, Reconstructive and Hand Surgeon, email 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite><Cite><Author>Professor of Vascular Surgery</Author><Year>2020</Year><RecNum>2</RecNum><record><rec-number>2</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334080">2</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Professor of Vascular Surgery,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by a Professor of Vascular Surgery, email received 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(Plastic Surgeon, 2020, Professor of Vascular Surgery, 2020).RationaleThe current Application (1608) focused on cryopreserved amnion membrane. As discussed above, advice from the Department of Health Medical Advisor was that all forms of amnion membrane products (e.g. dehydrated amnion membrane products) should be included in the assessment, to ensure sufficient evidence is available ADDIN EN.CITE <EndNote><Cite><Author>DoH Medical Advisor</Author><Year>2020</Year><RecNum>32</RecNum><DisplayText>(DoH Medical Advisor, 2020b)</DisplayText><record><rec-number>32</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584337882">32</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>DoH Medical Advisor,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication from DoH Medical Advisor, teleconference 18 February 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(DoH Medical Advisor, 2020b). In addition to the cryopreserved amnion membrane product discussed above, there are six other products listed under ARTG number 307979, which are dehydrated amnion membrane-based products used for wound healing ( REF _Ref35268278 \h Table 3). Two additional products are also listed under this number - EpiFix Injectable and AmnioFix Injectable. These are injectable amnion membrane treatments for chronic plantar fasciitis, and are not relevant to this application. Table SEQ Table \* ARABIC 3ARTG Listing for cryopreserved amnionARTG numberStart dateSponsorCategoryProduct nameProduct typeIntended use30797908/08/2018Vicki Partridge Pty LtdBiological Included Class 2Foetal membranes, dehydrated, irradiated (EpiFix, AmnioFix, EpiFix Fenestrated, EpiXL, EpiFix Mesh, AmnioFix Wrap)AmnionFor treatment of acute and chronic wounds to enhance healingSource: ARTG Website.The Applicant claimed that cryopreserved amnion may have better efficacy than dehydrated. Forms of amnions. Therefore, the Assessment Group suggests that if sufficient evidence is available, the assessment phase should investigate whether different forms of amnion membrane product have differing safety and effectiveness if evidence permits this analysis. PASC agreed with the assessment group that the submission should investigate whether different forms of amnion membrane (e.g.?cryopreserved or dehydrated) have differing safety and effectiveness, if evidence permits this analysis.It is not clear how frequently amnion needs to be re-applied. The Applicant advised that re-application may be required every 7-21 days. The Assessment Group suggests that the assessment phase should look at available data on re-application for each subpopulation, and the economic evaluation should undertake sensitivity analysis to explore this issue.PASC agreed with the assessment group that the submission should include data on the frequency of reapplication of amnion membrane, and explore this in sensitivity analyses in the economic evaluation. ComparatorPopulation 1: Ophthalmic conditionsExpert advice is that the most appropriate comparator for the SJS, TEN, burns and chronic corneal wound subpopulations would be supportive care. As described in the Population section of this PICO, this entails a combination of topical steroids, topical cycloplegic agents, pain relief, oral tetracycline and tissue debridement. The exact combination of treatments and frequency of application is dependent on the nature of the injury ADDIN EN.CITE <EndNote><Cite><Author>Associate Professor of Ophthalmology</Author><Year>2020</Year><RecNum>1</RecNum><DisplayText>(Associate Professor of Ophthalmology, 2020)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584333988">1</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Associate Professor of Ophthalmology,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by an Associate Professor of Ophthalmology, phone call, 27 February 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(Associate Professor of Ophthalmology, 2020).For pterygium surgery, the most relevant comparator would be conjunctival autograft ADDIN EN.CITE <EndNote><Cite><Author>Noureddin</Author><Year>2016</Year><RecNum>14</RecNum><DisplayText>(Noureddin and Yeung, 2016)</DisplayText><record><rec-number>14</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584335597">14</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Noureddin, G. S.</author><author>Yeung, S. N.</author></authors></contributors><auth-address>Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, BC, Canada.</auth-address><titles><title>The use of dry amniotic membrane in pterygium surgery</title><secondary-title>Clin Ophthalmol</secondary-title><alt-title>Clinical ophthalmology (Auckland, N.Z.)</alt-title></titles><periodical><full-title>Clin Ophthalmol</full-title><abbr-1>Clinical ophthalmology (Auckland, N.Z.)</abbr-1></periodical><alt-periodical><full-title>Clin Ophthalmol</full-title><abbr-1>Clinical ophthalmology (Auckland, N.Z.)</abbr-1></alt-periodical><pages>705-12</pages><volume>10</volume><edition>2016/05/05</edition><keywords><keyword>amniotic membrane</keyword><keyword>conjunctival autograft</keyword><keyword>cornea</keyword><keyword>pterygium</keyword></keywords><dates><year>2016</year></dates><isbn>1177-5467 (Print)
1177-5467</isbn><accession-num>27143848</accession-num><urls></urls><custom2>PMC4841395</custom2><electronic-resource-num>10.2147/opth.S80102</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>(Noureddin and Yeung, 2016). For other corneal surgeries, the most relevant comparator would be continued supportive care ADDIN EN.CITE <EndNote><Cite><Author>Associate Professor of Ophthalmology</Author><Year>2020</Year><RecNum>1</RecNum><DisplayText>(Associate Professor of Ophthalmology, 2020)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584333988">1</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Associate Professor of Ophthalmology,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by an Associate Professor of Ophthalmology, phone call, 27 February 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(Associate Professor of Ophthalmology, 2020).PASC confirmed the proposed comparators.Population 2: Chronic skin woundsFor Population 2 the proposed comparators are:UrgoStart dressing (diabetic foot and venous insufficiency ulcers)Split thickness skin grafts (diabetic foot ulcers, venous insufficiency ulcers)For venous insufficiency ulcers and diabetic foot ulcers, expert advice is that the most appropriate comparator is either use of the UrgoStart dressing or skin grafts. Expert advice is that the most relevant guidelines used in Australia to determine care for chronic skin wounds are the recently published International Working Group on the Diabetic Foot (IWGDF) Guidelines: Wound Healing Interventions Guideline ADDIN EN.CITE <EndNote><Cite><Author>IWGDF</Author><Year>2019</Year><RecNum>27</RecNum><DisplayText>(IWGDF, 2019)</DisplayText><record><rec-number>27</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584337155">27</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>IWGDF,</author></authors></contributors><titles><title>IWGDF Practical guidelines on the prevention and management of diabetic foot disease</title></titles><volume>2020</volume><number>16 March</number><dates><year>2019</year></dates><publisher>International Working Group on the Diabetic Foot </publisher><urls><related-urls><url>;(IWGDF, 2019).UrgoStart is an interactive sucrose-octasulfate impregnated dressing, which has recently been shown to improve wound healing compared to non-interactive dressings in chronic diabetic and venous insufficiency ulcers in a multicentre, double blind RCT PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5FZG1vbmRzPC9BdXRob3I+PFllYXI+MjAxODwvWWVhcj48
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ADDIN EN.CITE.DATA (Edmonds et al., 2018). The dressing is designed to create a moist wound environment using a technology-lipido-colloid layer, which promotes healing as well as inhibit protease activity via the nano-oligosaccharide factor ADDIN EN.CITE <EndNote><Cite><Author>NICE</Author><Year>2019</Year><RecNum>33</RecNum><DisplayText>(NICE, 2019b)</DisplayText><record><rec-number>33</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584338220">33</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>NICE,</author></authors></contributors><titles><title>UrgoStart for treating diabetic foot ulcers and leg ulcers</title></titles><volume>2020</volume><number>16 March</number><dates><year>2019</year></dates><publisher>National Institute for Health and Care Excellence</publisher><urls><related-urls><url>;(NICE, 2019b).The use of the UrgoStart has recently been recommended by the National Institute for Health and Care Excellence (NICE) Guidelines for use in venous insufficiency and diabetic foot ulcers ADDIN EN.CITE <EndNote><Cite><Author>NICE</Author><Year>2019</Year><RecNum>33</RecNum><DisplayText>(NICE, 2019b)</DisplayText><record><rec-number>33</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584338220">33</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>NICE,</author></authors></contributors><titles><title>UrgoStart for treating diabetic foot ulcers and leg ulcers</title></titles><volume>2020</volume><number>16 March</number><dates><year>2019</year></dates><publisher>National Institute for Health and Care Excellence</publisher><urls><related-urls><url>;(NICE, 2019b), as well as being recommended in the IWGDF Guidelines ADDIN EN.CITE <EndNote><Cite><Author>IWGDF</Author><Year>2019</Year><RecNum>27</RecNum><DisplayText>(IWGDF, 2019)</DisplayText><record><rec-number>27</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584337155">27</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>IWGDF,</author></authors></contributors><titles><title>IWGDF Practical guidelines on the prevention and management of diabetic foot disease</title></titles><volume>2020</volume><number>16 March</number><dates><year>2019</year></dates><publisher>International Working Group on the Diabetic Foot </publisher><urls><related-urls><url>;(IWGDF, 2019). Expert advice is that this would be an appropriate comparator for both diabetic foot ulcers and venous insufficiency ulcers and that the product is currently used in Australia for these types of chronic skin wound ADDIN EN.CITE <EndNote><Cite><Author>Professor of Vascular Surgery</Author><Year>2020</Year><RecNum>2</RecNum><DisplayText>(Professor of Vascular Surgery, 2020)</DisplayText><record><rec-number>2</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334080">2</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Professor of Vascular Surgery,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by a Professor of Vascular Surgery, email received 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(Professor of Vascular Surgery, 2020).UrgoStart is listed on the ARTG ( REF _Ref35268603 \h Table 4) and advice from the manufacturer is that the dressing is readily available in Australia and is listed on the majority of State Department of Health contracts ADDIN EN.CITE <EndNote><Cite><Author>UrgoStart Manufacturer</Author><Year>2020</Year><RecNum>35</RecNum><DisplayText>(UrgoStart Manufacturer, 2020)</DisplayText><record><rec-number>35</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584338455">35</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>UrgoStart Manufacturer,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication from UrgoStart Manufacturer, email recieved 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(UrgoStart Manufacturer, 2020).Table SEQ Table \* ARABIC 4ARTG Listing for UrgoStartARTG numberStart dateSponsorCategoryProduct nameProduct typeIntended use13424022/12/2006Bayport Brands Pty LtdMedical Device Included Class IIbDressing, hydrogelSingle device productTreatment of low to high exudative wounds, such as acute wounds (burns, dermabrasions etc.), chronic wounds (leg ulcers, pressure ulcers, diabetes ulcers etc.), and skin lesions caused by congenital epidermolysis bullosaSource: ARTG Website.Advice from a plastic surgeon is that split thickness skin grafts would also be an appropriate comparator for diabetic foot ulcers and venous insufficiency ulcers and are currently used routinely for these types of chronic skin wounds ADDIN EN.CITE <EndNote><Cite><Author>Plastic Surgeon</Author><Year>2020</Year><RecNum>3</RecNum><DisplayText>(Plastic Surgeon, 2020)</DisplayText><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334150">3</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Plastic Surgeon,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by a Plastic, Reconstructive and Hand Surgeon, email 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(Plastic Surgeon, 2020). Split thickness skin grafts involve the transfer of skin from donor site on the patient’s body to the wound. Skin grafts provide protection to the wound, maintain temperature and prevent water loss like normal skin; however, they do not have blood supply and are reliant on the vascularisation of the wound bed for growth ADDIN EN.CITE <EndNote><Cite><Author>Braza</Author><Year>2019</Year><RecNum>36</RecNum><DisplayText>(Braza and Fahrenkopf, 2019)</DisplayText><record><rec-number>36</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584338552">36</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Braza, M.</author><author>Fahrenkopf, M.</author></authors></contributors><titles><title>Split-Thickness Skin Grafts</title></titles><volume>2020</volume><number>16 March</number><dates><year>2019</year></dates><publisher>NCBI</publisher><urls><related-urls><url>;(Braza and Fahrenkopf, 2019). MBS items relevant to split-thickness skin grafts for chronic skin wounds are listed below. MBS item 45400 was claimed 923 times in 2018/19 while item 45403 was claimed 496 times.Table SEQ Table \* ARABIC 5MBS listing for items 45400 and 45403Group T8 – Surgical OperationsSubgroup 13 – Plastic and Reconstructive SurgerySubheading 3 – Free Grafts45400FREE GRAFTING (split skin) of a granulating area, small Multiple Operation Rule(Anaes.) Fee: $208.00 Benefit: 75% = $156.00 85% = $176.80 Group T8 – Surgical OperationsSubgroup 13 – Plastic and Reconstructive SurgerySubheading 3 – Free Grafts45403FREE GRAFTING (split skin) of a granulating area, extensiveMultiple Operation Rule(Anaes.) (Assist.)Fee: $414 Benefit: 75% = $310.50 85% = $351.90 Source: MBS Online websiteThere is some evidence that skin grafts may improve healing in diabetic foot ulcers compared to standard wound care and NICE Guidelines recommend these may be used on the advice of the multidisciplinary foot care service ADDIN EN.CITE <EndNote><Cite><Author>NICE</Author><Year>2019</Year><RecNum>37</RecNum><DisplayText>(NICE, 2019a)</DisplayText><record><rec-number>37</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584338650">37</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>NICE,</author></authors></contributors><titles><title>Diabetic foot problems: prevention and management. NICE guideline [NG19]</title></titles><volume>2020</volume><number>16 March</number><dates><year>2019</year></dates><publisher>National Institute of Health and Care Excellence</publisher><urls><related-urls><url>;(NICE, 2019a). For venous insufficiency ulcers, the Scottish Intercollegiate Guidelines Network (SIGN) management of chronic venous leg ulcers guidelines do not recommend use of split skin grafts as there was insufficient evidence showing an improvement in healing over standard care for chronic skin wounds ADDIN EN.CITE <EndNote><Cite><Author>SIGN</Author><Year>2010</Year><RecNum>24</RecNum><DisplayText>(SIGN, 2010)</DisplayText><record><rec-number>24</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584336781">24</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>SIGN,</author></authors></contributors><titles><title>Management of chronic venous leg ulcers </title></titles><volume>2020</volume><number>16 March</number><dates><year>2010</year></dates><publisher>Healthcare Improvement Scotland</publisher><urls><related-urls><url>;(SIGN, 2010).For arterial insufficiency ulcers, the key component of care is improving vascularisation; PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5WU0dCSTwvQXV0aG9yPjxZZWFyPjIwMjA8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (VSGBI, 2020, Broderick et al., 2020)Therefore, the most appropriate comparator appears to be standard wound care as described in Population section. PASC confirmed the proposed comparators.PASC suggested the assessment group could include skin grafts as an additional comparator for the chronic venous insufficiency ulcer population, if there is sufficient evidence to permit this comparison. The PASC also noted the use of skin grafts should be included towards the end of any treatment algorithm. The comparators have been updated to reflect PASC’s advice.Population 3: Acute skin wounds 3aBurns where patients require a dermal substitute before skin grafting can take placeClinical feedback is that dermal substitutes are the most relevant comparator to amnion membrane in this population.In Australia there are two dermal substitutes which are used to provide a bridge to skin grafts in patients with burns, IntegraTM (Life Sciences Corp, Plainsboro, NJ) and NovoSorbTM Biodegradable Temporising Matrix (BTM) (PolyNovo Biomaterials Pty Ltd, Melbourne, Australia).Integra is a dermal regeneration template constructed from bovine collagen and shark condriotin-6-sulphate ADDIN EN.CITE <EndNote><Cite><Author>Lohana</Author><Year>2014</Year><RecNum>29</RecNum><DisplayText>(Lohana et al., 2014)</DisplayText><record><rec-number>29</rec-number><foreign-keys><key app="EN" db-id="savr5f0f8de9acew9pgprdpxw0v9z5vz0xfz" timestamp="1541379411">29</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Lohana, P.</author><author>Hassan, S.</author><author>Watson, S. B.</author></authors></contributors><titles><title>Integra? in burns reconstruction: Our experience and report of an unusual immunological reaction</title><secondary-title>Annals of burns and fire disasters</secondary-title></titles><periodical><full-title>Annals of burns and fire disasters</full-title></periodical><pages>17-21</pages><volume>27</volume><number>1</number><edition>03/31</edition><dates><year>2014</year></dates><publisher>Euro-Mediterranean Council for Burns and Fire Disasters - MBC</publisher><isbn>1592-9558
1592-9566</isbn><accession-num>25249843</accession-num><urls><related-urls><url>;(Lohana et al., 2014). The structure provides a scaffold for neodermis formation. Australian guidelines state that Integra should only be applied by a burns medical specialist and is indicated for full thickness burns over flexor joints ADDIN EN.CITE <EndNote><Cite><Author>Connolly</Author><Year>2014</Year><RecNum>18</RecNum><DisplayText>(Connolly, 2014)</DisplayText><record><rec-number>18</rec-number><foreign-keys><key app="EN" db-id="savr5f0f8de9acew9pgprdpxw0v9z5vz0xfz" timestamp="1541030821">18</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Connolly, S.</author></authors></contributors><titles><title>Clinical Practice Guidelines: Burn Patient Management. ACI Statewide Burn Injury Service</title></titles><volume>2018</volume><number>1 November</number><dates><year>2014</year></dates><publisher>NSW Agency for Clinical Innovation,</publisher><urls><related-urls><url>;(Connolly, 2014). Novosorb-BTM is a synthetic dermal replacement scaffold comprised of polyurethane open-cell foam PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XYWdzdGFmZjwvQXV0aG9yPjxZZWFyPjIwMTU8L1llYXI+
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ADDIN EN.CITE.DATA (Wagstaff et al., 2015, Greenwood et al., 2018). The dressing is intended to: temporise extensively debrided wounds before spit-skin grafting can take place; sustain grafts once integrated; integrate vascular tissue to create a neodermis; and, to reduce wound contraction ADDIN EN.CITE <EndNote><Cite><Author>Wagstaff</Author><Year>2015</Year><RecNum>22</RecNum><DisplayText>(Wagstaff et al., 2015)</DisplayText><record><rec-number>22</rec-number><foreign-keys><key app="EN" db-id="savr5f0f8de9acew9pgprdpxw0v9z5vz0xfz" timestamp="1541044482">22</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Wagstaff, Marcus J. D.</author><author>Schmitt, Bradley J.</author><author>Coghlan, Patrick</author><author>Finkemeyer, James P.</author><author>Caplash, Yugesh</author><author>Greenwood, John E.</author></authors></contributors><titles><title>A biodegradable polyurethane dermal matrix in reconstruction of free flap donor sites: a pilot study</title><secondary-title>Eplasty</secondary-title></titles><periodical><full-title>Eplasty</full-title></periodical><pages>e13-e13</pages><volume>15</volume><dates><year>2015</year></dates><publisher>Open Science Company, LLC</publisher><isbn>1937-5719</isbn><accession-num>25987938</accession-num><urls><related-urls><url>;(Wagstaff et al., 2015). Both products are listed on the ARTG ( REF _Ref35269098 \h Table 6).Table SEQ Table \* ARABIC 6ARTG Listing for Integra and Novosorb-BTMARTG number &Start dateSponsorCategoryProduct nameProduct typeIntended use15879627/01/2009Integra Neurosciences Pty LtdMedical Device Included Class IIIIntegra Dermal Regeneration Template single layer - Skin regeneration template, human-/animal-derivedSingle Device ProductTo add extra thickness where required (to the Integra bi-layer dermal replacement) for the postexcisional treatment of full thickness and partial-thickness injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient. It is also indicated for use in reconstruction of postexcisional, full-thickness defects of the integument where there is, in the opinion of the treating surgeon, a potential benefit to the patient by improving the reconstructive outcome or decreasing their mortality/morbidity30821714/08/2018PolyNovo Biomaterials Pty LtdMedical Device Included Class IIINovoSorb BTM - Dressing, absorbableSingle Device ProductTemporize dermal injuries, where the dermis has been decimated or lost, and to facilitate dermal repair by providing temporary closure of the wound and a scaffold for the generation of a neodermisSource: ARTG Website.3bPatients with a graft donor site wound The Victorian Adult Burns Service at the Alfred Hospital reported that graft-site wounds are usually dressed post-operatively, with xeroform and a secondary gauze layer ADDIN EN.CITE <EndNote><Cite><Author>VABS</Author><Year>2019</Year><RecNum>43</RecNum><DisplayText>(VABS, 2019b)</DisplayText><record><rec-number>43</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584918008">43</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>VABS,</author></authors></contributors><titles><title>Donor Site Management</title></titles><volume>2020</volume><number>23 March</number><dates><year>2019</year></dates><publisher>Victorian Adult Burns Service At The Alfred</publisher><urls><related-urls><url>;(VABS, 2019b). Xeroform is a non-adhesive paraffin dressing. Other dressings used for the graft donor site may include foam, hydrocolloid, silicone membrane, alginate, and absorbent acrylic dressings, with gauze or foam as secondary dressings ADDIN EN.CITE <EndNote><Cite><Author>Romanelli</Author><Year>2019</Year><RecNum>42</RecNum><DisplayText>(Romanelli et al., 2019)</DisplayText><record><rec-number>42</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584917809">42</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Romanelli, M.</author><author>Serena, T.</author><author>Kimble, R.</author><author>Han, S.</author><author>Kim, J.</author><author>Cruz, J.</author><author>Chong, S.</author><author>AL Assar, M.</author></authors></contributors><titles><title>Skin graft donor site management in the treatment of burns and hard-to-heal wounds</title></titles><volume>2020</volume><number>23 March</number><dates><year>2019</year></dates><publisher>Wounds International</publisher><urls><related-urls><url>;(Romanelli et al., 2019). Standard wound dressing is therefore suggested as the most appropriate comparator for this subpopulation, as currently defined. 3cPatients requiring a skin graft fixatorFor skin graft fixation, literature review indicated that traditional methods of graft-fixation include either use of staples, stitches and microporous tape PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb2hhbW1hZGk8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFy
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ADDIN EN.CITE.DATA (Mohammadi et al., 2013). Therefore, it is suggested that traditional fixation methods are be the most appropriate comparators. Recent literature has investigated the use of negative pressure dressing for skin-graft fixation. It is not known whether this technique is commonly used in Australia. 3dPatients with toxic epidermal necrolysis skin lesions requiring dressing For patients with TEN, the suggested comparator to amnion membrane is Biobrane, a skin substitute used in Australia for superficial burn injuries. Biobrane contains pig collagen and provides wound closure and supports epithelisation ADDIN EN.CITE <EndNote><Cite><Author>Ngan</Author><Year>2016</Year><RecNum>50</RecNum><DisplayText>(Ngan et al., 2016, VABS, 2019a)</DisplayText><record><rec-number>50</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584920236">50</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Ngan, V.</author><author>Oakley, A.</author><author>Dyall-Smith, D.</author></authors></contributors><titles><title>Stevens–Johnson syndrome / toxic epidermal necrolysis</title></titles><volume>2020</volume><number>23 March</number><dates><year>2016</year></dates><publisher>DermNetNZ</publisher><urls><related-urls><url> app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584920786">53</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>VABS,</author></authors></contributors><titles><title>Biobrane Management</title></titles><volume>2020</volume><number>23 March</number><dates><year>2019</year></dates><publisher>Victorian Adult Burns Service At The Alfred</publisher><urls><related-urls><url>;(Ngan et al., 2016, VABS, 2019a). PASC confirmed the proposed comparators.For the three new subpopulations in Population 3 (3b, 3c and 3d), PASC agreed with the suggested comparators from the assessment group, and agreed that expert advice was required on traditional skin graft fixation methods.The Assessment Group noted that expert advice has been sought, as to the current standard of care for skin graft fixation in Australia, however it was not received prior to finalising this PICO. It is recommended that the assessment phase should investigate what comparators are used in the literature and confer with an expert to ensure these are relevant to Australian clinical practice.RationaleOphthalmic indicationsExpert advice noted that some other rare treatments could be used for difficult to heal ophthalmic injuries (for example stem cell transplants or surgery to semi-permanently close the eye; however, these are not standard practice in Australia and therefore should not constitute comparators for the assessment ADDIN EN.CITE <EndNote><Cite><Author>Plastic and Reconstructive Surgeon</Author><Year>2018</Year><RecNum>4</RecNum><DisplayText>(Plastic and Reconstructive Surgeon, 2018)</DisplayText><record><rec-number>4</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334365">4</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Plastic and Reconstructive Surgeon,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication received from a Plastic and Reconstructive Surgeon, phonecall, 16 October 2018</title></titles><dates><year>2018</year></dates><urls></urls></record></Cite></EndNote>(Plastic and Reconstructive Surgeon, 2018).Chronic woundsMany other skin substitute products are available for treating chronic wounds. Expert advice is that these are not routinely used in Australia; therefore, these products have not been included as comparators ADDIN EN.CITE <EndNote><Cite><Author>Professor of Vascular Surgery</Author><Year>2020</Year><RecNum>2</RecNum><DisplayText>(Professor of Vascular Surgery, 2020)</DisplayText><record><rec-number>2</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334080">2</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Professor of Vascular Surgery,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication by a Professor of Vascular Surgery, email received 12 March 2020</title></titles><dates><year>2020</year></dates><urls></urls></record></Cite></EndNote>(Professor of Vascular Surgery, 2020). Further, use of these products is not recommended by IWGDF guidelines ADDIN EN.CITE <EndNote><Cite><Author>IWGDF</Author><Year>2019</Year><RecNum>27</RecNum><DisplayText>(IWGDF, 2019)</DisplayText><record><rec-number>27</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584337155">27</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>IWGDF,</author></authors></contributors><titles><title>IWGDF Practical guidelines on the prevention and management of diabetic foot disease</title></titles><volume>2020</volume><number>16 March</number><dates><year>2019</year></dates><publisher>International Working Group on the Diabetic Foot </publisher><urls><related-urls><url>;(IWGDF, 2019). NICE guidelines state these can be used for diabetic foot ulcers but only on the advice of the multidisciplinary foot care service ADDIN EN.CITE <EndNote><Cite><Author>NICE</Author><Year>2019</Year><RecNum>37</RecNum><DisplayText>(NICE, 2019a)</DisplayText><record><rec-number>37</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584338650">37</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>NICE,</author></authors></contributors><titles><title>Diabetic foot problems: prevention and management. NICE guideline [NG19]</title></titles><volume>2020</volume><number>16 March</number><dates><year>2019</year></dates><publisher>National Institute of Health and Care Excellence</publisher><urls><related-urls><url>;(NICE, 2019a). Negative pressure wound therapy is only recommended for post-surgical wounds in patients with diabetic ulcers ADDIN EN.CITE <EndNote><Cite><Author>IWGDF</Author><Year>2019</Year><RecNum>27</RecNum><DisplayText>(IWGDF, 2019, NICE, 2019a)</DisplayText><record><rec-number>27</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584337155">27</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>IWGDF,</author></authors></contributors><titles><title>IWGDF Practical guidelines on the prevention and management of diabetic foot disease</title></titles><volume>2020</volume><number>16 March</number><dates><year>2019</year></dates><publisher>International Working Group on the Diabetic Foot </publisher><urls><related-urls><url> app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584338650">37</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>NICE,</author></authors></contributors><titles><title>Diabetic foot problems: prevention and management. NICE guideline [NG19]</title></titles><volume>2020</volume><number>16 March</number><dates><year>2019</year></dates><publisher>National Institute of Health and Care Excellence</publisher><urls><related-urls><url>;(IWGDF, 2019, NICE, 2019a)Both NICE and IWGDF Guidelines do not recommend the use electrical stimulation therapy, growth factors and hyperbaric oxygen therapy PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5JV0dERjwvQXV0aG9yPjxZZWFyPjIwMTk8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (IWGDF, 2019, McCosker et al., 2019).BurnsFor Population 3, expert advice is that BioBrane and Suprathel are indicated for use in superficial burns and are therefore not suitable comparators to amnion membrane in the proposed population for patients with burns ADDIN EN.CITE <EndNote><Cite><Author>Plastic and Reconstructive Surgeon</Author><Year>2018</Year><RecNum>4</RecNum><DisplayText>(Plastic and Reconstructive Surgeon, 2018)</DisplayText><record><rec-number>4</rec-number><foreign-keys><key app="EN" db-id="zr5taf5wza5tv9e2de7pp0wj0fe5vdxrtzax" timestamp="1584334365">4</key></foreign-keys><ref-type name="Personal Communication">26</ref-type><contributors><authors><author>Plastic and Reconstructive Surgeon,</author></authors><secondary-authors><author>J Duncan</author></secondary-authors></contributors><titles><title>Personal Communication received from a Plastic and Reconstructive Surgeon, phonecall, 16 October 2018</title></titles><dates><year>2018</year></dates><urls></urls></record></Cite></EndNote>(Plastic and Reconstructive Surgeon, 2018).OutcomesPatient-relevant outcomesPopulation 1: Ophthalmic conditionsAny adverse events associated with amnion membrane including any infection rates and donor derived infectionsAny adverse events associated with comparators including any infection ratesWound healing (rate of healing frequency of compete healing, time to healing)Visual acuity PainTime to return to work/activityLength of hospital stayDisease recurrence (particularly for pterygium surgery)Quality of lifePopulation 2: Chronic skin woundsAny adverse events associated with amnion membrane including any infection rates and donor derived infectionsAny adverse events associated with comparators including any infection ratesWound healing (change in wound size, rate of healing frequency of compete healing, time to healing)Scarring and cosmesis outcomesPainPatient movement Limb salvage ratesAmputation ratesTime to return to work/activityLength of hospital stayQuality of lifePopulation 3: Acute skin wounds Any adverse events associated with amnion membrane including any infection rates and donor derived infectionsAny adverse events associated with comparators including any infection ratesWound healing (change in wound size, rate of healing frequency of compete healing, time to healing)Graft loss rates/graft takeScarring and cosmesis outcomesPainPatient movement Time to return to work/activityLength of hospital stayQuality of lifeHealthcare system outcomes (for all three populations)Costs associated with the intervention including resource use to deliver intervention and follow-up costsCosts associated with the comparator including resource use to deliver intervention and follow-up costsChanges in utilisation of healthcare costs during follow-up period (for example due to changes in hospitalisation rates and lengths, those required to treat adverse events)PASC confirmed that the proposed outcomes were appropriate.Other considerationsIt is suggested that the assessment report also collects/presents and analyses data on:Any subpopulations where amnion membrane may have different effectiveness or safety outcomesDifferences in safety and effectives between amnion membrane preparations/formulationsVariance in amnion membrane reapplication rates and the impact of this on economics via sensitivity analysis.It is likely that for Populations 2 and 3 indirect or na?ve comparisons will be required.Current and proposed clinical management algorithmsPASC confirmed the proposed clinical management algorithms for Population 1 and 2. However, the clinical algorithms for Population 3 will need to be updated to reflect the applicant’s request to include three additional sub-groups within Population 3. The clinical algorithms below have been updated accordingly. Current clinical management algorithm for Population 1Source: produced by the Assessment Group based on published evidence and expert advice PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Bc3NvY2lhdGUgUHJvZmVzc29yIG9mIE9waHRoYWxtb2xv
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ADDIN EN.CITE.DATA (Associate Professor of Ophthalmology, 2020, Bunya and Chang, 2019, Gupta et al., 2014, Hemmati and Colby, 2020, Hsu et al., 2012, Noureddin and Yeung, 2016, Sharma et al., 2016, Slentz and Hemmati, 2013, Wander and Kroger, 2020)Proposed clinical management algorithm for Population 1Source: produced by the Assessment Group based on published evidence and expert advice (Associate Professor of Ophthalmology, 2020, Bunya and Chang, 2019, Gupta et al., 2014, Hemmati and Colby, 2020, Hsu et al., 2012, Noureddin and Yeung, 2016, Sharma et al., 2016, Slenz and Hemmati, 2013, Wander and Kroger, 2020)Current clinical management algorithm for Population 2Source: Algorithm developed based on Expert Advice and published literature and Guidelines PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Eb0ggaWRlbnRpZmllZCBFeHBlcnQ8L0F1dGhvcj48WWVh
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ADDIN EN.CITE.DATA (DoH identified Expert, 2020, IWGDF, 2019, NICE, 2019b, NICE, 2019a, Plastic Surgeon, 2020, Professor of Vascular Surgery, 2020)Note: A Expert advice is that UrgoStart dressings are used in Australia.Proposed clinical management algorithm for Population 2Source: Algorithm developed based on Expert Advice and published literature and Guidelines PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Eb0ggaWRlbnRpZmllZCBFeHBlcnQ8L0F1dGhvcj48WWVh
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ADDIN EN.CITE.DATA (DoH identified Expert, 2020, IWGDF, 2019, NICE, 2019b, NICE, 2019a, Plastic Surgeon, 2020, Professor of Vascular Surgery, 2020)Note: A Expert advice is that UrgoStart dressings are used in Australia. Current clinical management algorithm for Population 3aBurns where patients require a dermal substitute before skin grafting can take placeSource: developed by the Assessment group based on expert advice and published literature PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CUkFOWjwvQXV0aG9yPjxZZWFyPjIwMTk8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (BRANZ, 2019, Plastic and Reconstructive Surgeon, 2018, Plastic Surgeon, 2020, Victorian Adults Burns Service at the Alfred, 2018)Abbreviations: BTM = NovoSorbTM Biodegradable Temporising Matrix, TBSA = total body surface areaNotes: A: Some small but deep partial and full thickness burns may require a skin graft. Proposed clinical management algorithm for Population 3aBurns where patients require a dermal substitute before skin grafting can take placeSource: developed by the Assessment group based on expert advice and published literature PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CUkFOWjwvQXV0aG9yPjxZZWFyPjIwMTk8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (BRANZ, 2019, Plastic and Reconstructive Surgeon, 2018, Plastic Surgeon, 2020, Victorian Adults Burns Service at the Alfred, 2018)Abbreviations: BTM = NovoSorbTM Biodegradable Temporising Matrix, TBSA = total body surface areaNotes: A: Some small but deep partial and full thickness burns may require a skin graft.Current clinical management algorithm for Population 3bPatients with a skin-graft donor site woundProposed clinical management algorithm for Population 3bPatients with a skin-graft donor site woundCurrent and proposed clinical management algorithms for Population 3cPatients requiring a skin graft fixatorThe current algorithm is shown of the left hand side, the proposed algorithm is on the rightCurrent and proposed clinical management algorithms for Population 3dPatients with TEN skin lesion requiring dressingThe current algorithm is shown of the left hand side, the proposed algorithm is on the rightProposed economic evaluationThe Applicant claimed that cryopreserved amnion membrane is non-inferior to other forms of amnion membrane. No claim was presented for the comparators listed in this PICO. It is suggested that:In Population 1: Compared to standard care, amnion is superior for effectiveness and non-inferior for safety outcomesIn Population 2: compared to advanced wound treatments (UrgoStart, split thickness skin grafts) amnion is superior for effectiveness and non-inferior for safetyIn Population 3: compared to dermal substitutes (BTM and Integra) amnion in non-inferior for safety and effectivenessIf a claim of superiority is supported a cost utility analysis is appropriate. If a claim of non-inferiority is supported, then a cost minimisation may be appropriate. PASC confirmed that the proposed economic evaluation was appropriate.Proposed MBS item descriptor and MBS feePASC noted that amnion membrane would be used under a range of existing MBS items, determined by the respective clinicians with varying costs for each item.The Applicant proposed that amnion be listed on the Prostheses List, with a proposed benefit as outlined in REF _Ref35263744 \h Table 7.Table SEQ Table \* ARABIC 7Proposed benefit for amnion products listed on Prosthesis ListAmnion sizeProposed benefit5 cm diameter circle$578.575 x 10 cm $1,446.1110 x 10 cm$2,892.87Source: Application FormThe Applicant advised that costs outlined in REF _Ref35263744 \h Table 7 have been derived, based on a unit price of $28.93 per cm2. This is based on (Application Form) costs of:Amnion membrane retrieval consumables ($9)Amnion membrane processing consumables ($1,332)Pathology testing ($4,767)Regulatory ($1,347)Staff ($2,316)Equipment depreciation and service ($532)Courier ($660).The unit cost also includes an estimated 15% unutilised product, with $2,923.32 for costs associated with tissue that is unable to be released, because of pathology results. A routine amnion membrane donation will produce a maximum of 24 x 20 cm2 grafts in a range of sizes.Consultation feedbackPASC noted the consultation feedback from the Royal Australian and New Zealand College of Ophthalmologists, which supported the application and noted that amnion membrane products would also be beneficial in the community setting to avoid hospital admission.Next stepsPASC advised that, upon ratification of the post-PASC PICO, the application can proceed to the Evaluation Sub-Committee (ESC) stage of the MSAC process.PASC noted the applicant has elected to progress its application as a DCAR (Department-contracted assessment report). PASC advised that the application should continue to progress as a single submission, ensuring subgroups analysis is carried out, where data permits. References ADDIN EN.REFLIST Abul, A., Karam, M. & Rahman, S. 2020. Human Amniotic Membrane: A New Option for Graft Donor Sites - Systematic Review and Meta-analysis. Int Wound J.Aihw. 2019. Procedures Data Cubes, Procedures and healthcare interventions (ACHI 10th edition), Australia, 2017-18 [Online]. Australian Institute of Health and Welfare. Available: [Accessed 16 March 2020].Aihw, Pointer, S. & Tovell, A. 2016. Hospitalised burn injuries, Australia, 2013–14. Injury research and statistics series no. 102. Cat. no. INJCAT 178 [Online]. Canberra: Australian Institute of Health and Welfare. Available: [Accessed 16 March 2020].Alavi, A., Sibbald, R. G., Mayer, D., Goodman, L., Botros, M., Armstrong, D. G., Woo, K., Boeni, T., Ayello, E. A. & Kirsner, R. S. 2014. Diabetic foot ulcers: Part II. Management. J Am Acad Dermatol, 70, 21.e1-24; quiz 45-6.Alexiadou, K. & Doupis, J. 2012. Management of diabetic foot ulcers. Diabetes therapy : research, treatment and education of diabetes and related disorders, 3, 4-4.Associate Professor of Ophthalmology. 2020. RE: Personal Communication by an Associate Professor of Ophthalmology, phone call, 27 February 2020. 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