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Background and Methodology

Background

In early 2012, one of the authors (L. M.) observed few clinicians receive formal training or education on medical adhesives and often select and use products containing adhesives without knowledge or consideration of application or removal techniques, durability, or aggressiveness of adhesion. An initial literature search on skin adhesives identified articles on skin properties, specific product evaluations, and comparative studies; however, information regarding use of medical adhesives was sparse. Outside of clinical textbooks on wound and ostomy care,1-3 no guidelines for clinical practice and skin safety were identified other than the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) Neonatal Skin Care Guideline4 and evidence-based recommendations/ national guidelines in Portuguese resulting from the 1st InterPele: Symposium on Skin Integrity Prevention Strategies, held in Angra dos Reis, Brazil, in March 2011.5

To remedy the situation, an interdisciplinary consensus summit involving 22 expert clinical stakeholders was held December 10th-11th , 2012, in St. Paul, Minnesota, to increase awareness of medical adhesive-related skin injury (MARSI) and define best practices for prevention of such injury. Goals of the summit were to establish consensus statements on the assessment, prevention, and treatment of MARSI; to define knowledge gaps regarding medical adhesives and skin safety, to document the spectrum of care settings and medical applications where MARSI occurs, and to identify research priorities for development of new adhesive technologies and protocols for skin protection.

Medical Adhesives & Safety Consensus Task Force

Three standing members of the 3M Skin Integrity Advisory Board were invited and agreed to serve an advisory role for the Summit. This Task Force assisted in the development of the conference objectives, identified relevant terms for a comprehensive literature search, reviewed the literature and identified key publications, drafted a state-of-the-science presentation, prepared draft consensus statements, participated in the consensus voting process, and served as authors for this manuscript.

Moderator

At the recommendation of the Task Force, Mikel Gray, of the University of Virginia, was invited to serve as the consensus moderator for the Summit. Dr. Gray has expertise in moderating consensus conferences and is knowledgeable about, but not directly vested in, the issue of medical adhesive safety and did not participate in the voting process.

Summit Planning and Facilitation

Magellan Medical Technology Consultants, Inc. of Minneapolis, MN, were contracted to plan and facilitate the Summit. Magellan supported the Task Force in their advisory role by moderating bi-weekly teleconferences; organizing and circulating literature search results, publications, and draft consensus statements; recruiting Summit participants, assisting in facilitating and coordinating the Summit; and providing writing and editorial assistance.

Medical Adhesives & Patient Safety Consensus Panel Members

Medical specialties and/or practice settings where medical adhesives are used were identified by the Task Force and by literature review. Potential representatives from each of these specialties and settings were recommended by Task Force members based on their expertise and/or interest in MARSI, identified by authorship of relevant key publications, and/or solicited from relevant professional organizations, with the goal of obtaining representation of as many relevant healthcare disciplines and practice settings as possible. Invitations to each potential representative were made via phone or e-mail, with background provided on the purpose of the meeting, meeting logistics, and the voting process for consensus statements presented and/or formulated at the Summit. Specialties represented by the 20 invited panel members agreeing to attend the Summit included critical care; dermatology; electrophysiology; geriatrics; infection prevention; infusion therapy; neonatology; oncology; orthopedics; pediatrics; perioperative; physical therapy; plastic surgery; and wound, ostomy, and continence. Researchers in the area of skin and wound care, including pressure ulcers, were also among the invited participants.

Literature Review

Literature reviews were conducted during September and October 2012. An initial search was conducted in the Scopus database using terms identified by the Task Force, which included adhesive(s), adhesive surgical tape, allergic contact dermatitis, bandages, barrier film, dressing, epidermal injury, epidermal stripping, fragile skin, irritant contact dermatitis, maceration, medical adhesive, medical adhesive tape, medical bandage, skin abrasion, skin injury, tape blister, and tape burn. As many of these key terms are broad, search limiters such as adhesive(s), adverse effects, skin injury, skin protection, and/or trauma were incorporated using the Boolean function “AND.” Based on an initial review of these records, it was decided to limit these results to articles published in English since 1990

An additional review was completed for studies investigating medical adhesive stripping published in English since 1990. This review included the following 5 databases: MEDLINE, EMBASE, BIOSIS Previews®, CHEMICAL ABSTRACTS, and EMcare. Search terms included keywords for bandage or dressing or tape combined with keywords for skin stripping. A separate search for relevant practice guidelines or procedures was conducted in the following databases: MEDLINE, EMBASE, BIOSIS Previews®, CHEMICAL ABSTRACTS, EMcare, and CINAHL. Search terms included indexing terms and keywords for skin injury combined with adhesive agents or tape. Textbooks were not included in these searches.

In addition to randomized clinical trials and comparison cohort studies, individual case studies, multiple cases series, clinical practice guidelines, consensus documents, practice surveys, laboratory studies, preclinical research studies, technical articles, letters to the editor, and product-related articles were retrieved. Publications outside the scope of the topic (ie, tissue adhesives, tissue glues, occupational exposure to acrylates, etc) were excluded and all remaining articles (n=167) were reviewed on a case-by-case basis by the Task Force for relevance to the topic; 88 of these (52.6%) were considered relevant.

In order to obtain a cross-section of key publications for consensus statement development and a manageable number of articles as background information for invited panel members, each relevant article was categorized according to medical specialty and practice setting. Task Force members then ranked each article on a scale of 1 to 3 (where 1 defined the lowest level of information and 3 the highest) while also including as many representative specialties/ practice settings as feasible. The 31 top-scoring articles (articles totaling 10 points or more) were identified as key publications.

State-of-the-Science

A pre-conference state-of-the-science presentation was developed by the Task Force to provide background information for invited panel members. The presentation included an overview of potential adverse consequences of medical adhesive usage and failure; a review of types of medical adhesives, medical adhesive tapes, dressings, skin protectants, and medical adhesive removers; definitions and photos of various types of medical adhesive-related skin injuries; and a review of the etiology and epidemiology of MARSI based on the relevant articles identified in the literature search. This presentation and the key publications were sent to the invited participants prior to the Summit.

Consensus Statement Development

Prior to the Summit, a set of draft consensus statements was developed by the Task Force to provide a framework for discussion during the Summit. Topics were primarily related to clinical practice and included definitions/ nomenclature, assessment, prevention, infection control, treatment, and future research. A set of “key concepts” (ie, statements of fact) regarding general principles, epidemiology, and etiology/pathophysiology of MARSI; principles of infection control; and cost were simultaneously developed as a means of providing a summary of the existing literature and discussion points.

Consensus Summit Format

The 2-day Summit began with a presentation summarizing the goals of the Summit, disclosures, pre-Summit activities, and the state-of-the-science. This was followed by a review of the key concepts and draft consensus statements. An interactive PowerPoint software program and wireless response system pads (IML ViewPoint Express and IML Click, IML, Minneapolis, MN) were used to allow anonymous interactive voting by Task Force and invited panel members, henceforth collectively referred to as panel members, and to capture responses. Each draft consensus statement was projected on an individual slide and read aloud by the moderator. In some cases, an initial vote was cast by the panel members, whereas in other cases panel members were allowed to provide feedback and suggest revisions to the statement prior to voting. The open discussion and anonymous voting facilitated maximum participation and input by the panel members and refinement and clarification of the consensus statements. Furthermore, the open discussion allowed for the suggestion and development of additional relevant consensus statements to be voted upon.

Consensus on each statement was obtained based on general principles outlined in Murphy and colleagues6, using 80% agreement as the criterion for consensus. If consensus was not achieved on the first vote, the statement was edited based on panel member input and a second, and sometimes third, vote was taken. In cases where consensus could not be reached, or if a statement was considered not relevant, consensus regarding deletion of the statement was obtained.

References

1. Bryant RA. Types of skin damage and differential diagnosis. In: Bryant R, Nix D, eds. Acute & Chronic Wounds: Current Management Concepts. 4th ed. St. Louis, MO: Elsevier Mosby; 2012:83-107.

2. Rolstad BS, Bryant RA, Nix DP. Topical management. In: Bryant R, Nix D, eds. Acute & Chronic Wounds: Current Management Concepts. 4th ed. St. Louis, MO: Elsevier Mosby; 2012:289-307.

3. Colwell JC. Principles of stomal management. In: Colwell JC, Goldberg MT, Carmel JE. Fecal & Urinary Diversions: Management Principles. 1st ed. St. Louis, MO: Elsevier Mosby; 2004:240-262.

4. Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN). Neonatal skin care. 2nd ed. Evidence-based clinical practice guideline. Washington, DC: AWHONN;2007.

5. Nasimoto MCG, Domansky RC. Prevenção de lesão causada por adesivos [Prevention of injury caused for adhesives]. In: Domansky RC, Borges EL, eds. Manual para Prevenção de Lesões de Pele: Recomendações Baseadas Em Evidências [The Handbook of Prevention of Skin Lesions: Evidence-based Recommendations]. Rio de Janeiro, Brazil: Editora Rubio Ltda; 2012:43-70.\

6. Murphy MK, Black NA, Lamping DL, et al. Consensus development methods, and their use in clinical guideline development. Health Technol Assessment. 1998; 2(3)::i-iv,

1-88.

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