RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,



“ASSESSMENT OF ANTIBIOTICS PRESCRIPTION IN SURGICAL

PROPHYLAXIS IN A TEACHING HOSPITAL”

m.PHARM DISSERTATION PROTOCOL

SUBMITTED TO THE

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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA,

BANGALORE

BY

MANJUNATH.G.GANDAGE

UNDER THE GUIDANCE OF

SYED HAFIZ ALI

M.Pharm

Department of PHARMACY PRACTICE

H.K.E’S SOCIETY’S College of Pharmacy,

Gulbarga-585 105

2010-11

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORE

ANNEXURE –II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

| | | |

|1. |NAME OF THE CANDIDATE |MR. MANJUNATH.G.GANDAGE |

| |AND ADDRESS |DEPARTMENT OF PHARMACY PRACTICE, |

| | |HKE SOCIETY’s COLLEGE OF PHARMACY, |

| | |SEDAM ROAD, |

| | |GULBARGA 585 105. |

| | |KARNATAKA. |

| | | |

|2. |NAME OF THE INSTITUTION |HKES ‘S COLLEGE OF PHARMACY, |

| | |SEDAM ROAD GULBARGA 585 105. |

| | |KARNATAKA. |

| | | |

|3. |COURSE OF STUDY AND SUBJECT |MASTER OF PHARMACY |

| | |IN |

| | |PHARMACY PRACTICE |

| | | |

|4. |DATE OF ADMISSION TO COURSE |14th JUNE 2010 |

| | | |

|5. |TITLE OF THE TOPIC |“ASSESSMENT OF ANTIBIOTIC PRESCRIPTION IN SURGICAL PROPHYLAXIS IN A TEACHING |

| | |HOSPITAL”. |

|6.0 |Brief resume of the intended work: |

| | 6.1 Need for the study: |

| |Approximately 30–50% of antibiotic use in hospital practice is now for surgical prophylaxis. However, between 30% and 90% of this |

| |prophylaxis is inappropriate. Most commonly, the antibiotic is either given at the wrong time. Wound infections are the commonest |

| |hospital-acquired infections in surgical patients. They result in increased antibiotic usage, increased costs and prolonged |

| |hospitalization. Surgical antibiotic prophylaxis is defined as the use of antibiotics to prevent infections at the surgical site. It |

| |must be clearly distinguished from pre-emptive use of antibiotics to treat early infection, for example perforated appendix, even |

| |though infection may not be clinically apparent1. |

| | |

| |The basic principle of antimicrobial prophylaxis in surgery is to achieve adequate serum and tissue drug levels that exceed, for the |

| |duration of the operation. Although the principles of antimicrobial prophylaxis in surgery are clearly established and several |

| |guidelines have been published, the implementation of these guidelines is problematic among surgeons2. |

| | |

| |The use of antimicrobial prophylaxis for selected surgical procedures is one of the measures used to prevent the development of a |

| |surgical site infection3. Administration of prophylaxis should be done within three hours after the start of the operation otherwise |

| |it significantly reduces its effectiveness but for maximum effect, it should be given just before or just after the start of the |

| |operation. Prophylaxis should be started preoperatively in most circumstances, ideally within 30 minutes of the induction of |

| |anesthesia. However, there may be situation where over riding factors alter the normal timing of administration4. |

| | |

| |For effective antimicrobial prophylaxis, antibiotics must be present in tissue at the surgical site throughout the operation in |

| |concentrations sufficient to prevent growth of contaminating pathogenic microorganisms. The dose and timing of antibiotic |

| |administration for prophylaxis should be based on the concentration- time profile of the drug in the surgical wound5. |

| | |

| | |

| |The National Academy of Sciences National Research Council classified surgical site infection based on the risk of intraoperative |

| |bacterial contamination. The classification includes, Clean, Clean-contaminated, Contaminated and Dirty. The clean surgery includes |

| |Cardiac, Thoracic, Vascular (aortic resection, groin incision), Orthopedic (Total joint replacement, internal fracture) and |

| |Neurosurgery. Clean-contaminated surgery includes head and neck, Gastroduodenal, Colorectal, Appendectomy, Billiary tract, |

| |Genitourinary tract. The contaminated surgery includes penetrating trauma; major technique break or major spillage from GI tract; |

| |acute, nonpurulent inflammation. The dirty surgery include penetrating trauma; preoperative perforation of viscera. The inappropriate|

| |or indiscriminate use of prophylactic antibiotics can increase the risk of drug toxicity, selection of resistant organisms, and |

| |costs6. |

| | |

| |The goal of this study is to assess the pattern of antibiotics usage in surgical prophylaxis. |

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| | |

| |6.2 Review of Literature: |

| | |

| |Tourmousogolou CE et al. Conducted a study on 898 patients out of which, 44.8% underwent a clean surgical operation and 55.2% |

| |underwent a clean contaminated surgical operation. Inguinal hernia repair and laparoscopic cholecystectomy were the commonest |

| |operations in each category. Second-generation cephalosporins were the most frequently prescribed antibiotics, in 67%. Although, only|

| |78.5% of procedures required prophylaxis, it was administered in 97.5%, so it was not justified and inappropriately administered in |

| |19%. It was revealed that 100% of patients received antibiotic prophylaxis on time. The choice of antimicrobial agent was appropriate|

| |in 70% and the duration of prophylaxis was optimal in 36.3%. The overall compliance rate of surgeons with guidelines for antibiotic |

| |prophylaxis was 36.3%2. |

| | |

| |Van kasteren MEE et al. Conducted a study between January 2000 and January 2001, 1763 procedures were studied. Antibiotic choice, |

| |duration, dose, dosing interval and timing of the first dose were concordant with the hospital guideline in 92%, 82%, 89%, 43% and |

| |50%, respectively. Overall adherence to all aspects of the guideline, however, was achieved in only 28%. Antibiotics were |

| |administered in 1712 procedures. In eight of these procedures, no antibiotics were recommended. These were all abdominal |

| |hysterectomies performed in the one hospital that did not recommend prophylaxis. In 11 cases, two types of antibiotic were |

| |administered, whereas only one was indicated. In one case, three types of antibiotic were administered, whereas only two were |

| |indicated. In intestinal surgery ceforoxime and metronidazole, cefamendole and metronidazole were prescribed3. |

| | |

| |Palikhe N et al. In their study found that most commonly used antibiotic regimen was Ampi/Genta (38.2%) and Ampi+Cloxa with Genta |

| |(36.1%). Penicillin group of antibiotics together with gentamicin was the preferred regimen. Quinolone group of antibiotic i.e. |

| |ciprofloxacin was also used together with gentamicin. Penicillin group of antibiotics (for example, Ampi+Cloxa) and cephalosporins |

| |(i.e. Cefuroxime, second generation cephalosporins) and ciprofloxacin were mainly used as prophylaxis for cholecystectomy. So the |

| |most preferable antibiotic was ampicillin/ gentamicin4. |

| | |

| |Puchades MS et al. Conducted a study to analyze the antibiotic prophylaxis, in which Sixty-nine of the 105 distributed |

| |questionnaires were returned completed. Thirteen percent of the surveyed surgeons would prescribe antibiotics to prevent |

| |postoperative wound infection when confronted with conventional tooth extraction lasting less than 5 minutes. In the case of surgery |

| |lasting more than 5 minutes, the percentage of participants that would prescribe antibiotics increased to 39%. When a mucoperiosteal |

| |flap was elevated or an ostectomy was performed, 87% and 100%, respectively, would prescribe antibiotic prophylaxis. Amoxicillin and |

| |its combination with clavulanic acid were the most commonly prescribed antibiotics7. |

| | |

| |Khorvash F et al. Carried a study on, one thousand patients (62% men and 38% women, 18-74 year old) who underwent surgical treatment.|

| |Surgical wound infections, based on the reported criteria, were aspirated for culturing within one plus grams staining of prepared |

| |smears. The prevalence of surgical site infections was 13.3% with 150 positive cultures, of 150 bacteria, isolated from surgical site|

| |infections staphylococcus aureus had most frequency (43%). Resistance of isolated organisms was 41.7% in amikacin, 65 and 78.6% in |

| |ceftazidime, 85.7% in ceftriaxone, 61.5% in ciprofloxacin. The most common gram negative organism was klebsiella in which 100 and 80%|

| |were sensitive to imipenem and meropenem. 17 cases were E.coli in which the most sensitivity was to merepenem (80%) and imipenem |

| |(77.8%). 13 cases of pseudomonas were detected in which 16.7% were resistance to imepenem and 8.3% to merepenem. So therefore total |

| |antibiotic resistance is increasing among surgical site infections8. |

| |6.3 Objectives of the study: |

| |General objectives: |

| |To assess the prescription pattern of antibiotics in surgical prophylaxis. |

| |Specific objectives: |

| |Demographic data of patients undergoing surgery. |

| |Type of surgery. . |

| |Antibiotic chosen (category of antibiotic used). |

| |Time of first Dose of antibiotic. |

| |Name, dose and duration of antibiotics used. |

| | |

|7.0 |Materials and methods: |

| |7.1 Source of data: |

| |Case sheet of the patient who will be undergoing surgery in the department of surgery at HKES’s Basaveshwar Teaching and General |

| |Hospital Gulbarga. |

| |7.2 Methods of collection of data: |

| |(Including sampling procedure, if ANY |

| | |

| |Study site: Study will be conducted at post operative ward department of surgery at HKES Basaveshwar Teaching and General Hospital, |

| |Gulbarga. |

| | |

| |Study duration: Study will be carried out for a period of 8 months ( June 2011 onwards) |

| | |

| |Study design: A prospective study. |

| | |

| |Study criteria: Patients undergoing surgery will be enrolled into the study by considering following criteria: |

| |Inclusion Criteria: |

| |Patients undergoing surgery. |

| |Patients of above 18 years and of either gender. |

| |Patients who were willing to participate in the study. |

| |Exclusion Criteria: |

| |Patients undergoing cranial surgery, Gynecological surgery. |

| |Study procedure: |

| |Study will be conducted at the Department of surgery. Patients undergoing surgery will be enrolled in the study considering the |

| |inclusion and exclusion criteria. Informed consent will be taken from each patient at the time of enrollment in to the study. Details|

| |regarding demography, disease and treatment will be collected from the case sheets of the patient in a specially designed patient |

| |data collection form. |

| |The use of antibiotics prescription in surgical prophylaxis, during the hospital stay and on discharge from the hospital is noted. |

| |Patient data analysis: |

| |The data will be analyze by using suitable statically method,such as student ‘T’ Test. |

| | |

| |7.3 Does the study require any investigations to be conducted on Patients or other human or animals? If so please describe briefly. |

| | |

| |No. The study does not require any investigations to be conducted on patients or other humans or animals. |

| | |

| |7.4 Has ethical clearance been obtained from your institution in case of 7.3 |

| |  |

| |The study has been applied for ethical clearance approval from the Institution’s Ethical committee. Approval is awaited.    |

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|8.0 |References |

| | |

| | |

| |Munckhof W. Antibiotics for surgical prophylaxis. Aust prescr 2005; 28:38-40. |

| | |

| |Tourmousoglou CE, Yiannakopoulou EC, Kalapothaki V, Bramis J, Papadopoulos S. Adherence to guidelines for antibiotic prophylaxis in |

| |general surgery: a critical appraisal. Journal of Antimicrobial Chemotherapy 2007:1-5. |

| | |

| |Kasteren MEE, Kullberg BJ, Boer AS, Groot M, Gyssesns IC. Adherence to local hospital guidelines for surgical antimicrobial |

| |prophylaxis: a multicentre audit in Dutch hospitals. Journal of antimicrobial chemotherapy 2003; 51:1389-96. |

| | |

| |Palikhe N, Pokharel A. Prescribing regimens of prophylactic antibiotic used in different surgeries. Katamandu University Medical |

| |Journal 2003; 2:216-24. |

| | |

| |Rosin E, Ebert S, Uphoff T, Evans M, Nancy J. Darken S. Penetration of Antibiotics into the surgical wound in a canine model. |

| |Antimicrobial agents and chemotherapy 1989; 33(2):700-4. |

| | |

| |Daniel JG, Thirion, Guglielmo BJ. Antimicrobial Prophylaxis for Surgical Procedure. Koda-Kimble MA et al. Applied Therapeutics. 9th |

| |edition. 2009; 57:1-8. |

| | |

| |Puchades M, Vilas J, Castellon EV, Beriniaytes L, Escoda C. Analysis of the antibiotic prophylaxis prescribed by Spanish oral |

| |surgeons. Med oral patol oral cir bucal 2009; 14(10):533-7. |

| | |

| |Khorvash F, et al. Antimicrobial susceptibility pattern of microorganisms involved in the pathogenesis of surgical site infection |

| |(SSI); a 1 year of surveillance. Pakistan journal of medical sciences 2008; 11(15):1940-44. |

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|9. |Signature of Candidate | |

| | |MANJUNATH.G .GANDAGE. |

| | |This project will help asses the pattern of antibiotics usage in surgical |

|10. |Remarks of the Guide |prophylaxis. Hence recommended for registration. |

|11 |Name and Designation of | |

| | |SYED HAFIZ ALI. |

| |11.1 Guide |Assistant Professor |

| | |Dept. of Pharmacy Practice, |

| | |HKES’S College of Pharmacy |

| | |Gulbarga-585105. |

| | | |

| |Signature | |

| | |KALAYANI.B.BIRADAR |

| |11.2 Co-Guide ( IF ANY ) |LECTURER |

| | |Dept. of Pharmacy Practice, |

| | |HKES’s College of Pharmacy |

| | |Gulbarga-585105. |

| | | |

| |Signature | |

| | |NEELEKANT REDDY.PATIL. |

| |11.3 Head of the Department |Assistant Professor & HOD |

| | |Dept. of Pharmacy Practice, |

| | |HKES’s College of Pharmacy |

| | |Gulbarga-585105. |

| | | |

| |Signature | |

| | | |

|12 |Remarks of the Chairman and | |

| |Principal | |

| | | |

| | | |

| |Signature | |

| | |Dr. S. APPALA RAJU M. Pharm. PhD |

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