Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair

Study Overview
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Brief Summary
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Aim of this study is to measure the effectiveness of topical gentamicin to prevent post-operative infection in inguinal tension-free hernia repair operation.Secondary aim is, if it is effective as a prophylactic agent, to compare it's effect with intra venous single dose cefazolin sodium prophylaxis.

Detailed Description
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This study is a single blind prospective randomized trial. To measure and compare the effectiveness intra-operative topical gentamicin application in tension-free inguinal hernia repair in contrast to intravenous peri-operative prophylactic cefazolin sodium and combination of gentamicin and cephazolin this study is designed. The patients are grouped randomly in to two groups: Group1;intravenous cefazolin sodium Group2;topical gentamicin Group3:topical gentamicin and intravenous cefazolin sodium As a control group we decided to use the data of control groups ( without any prophylactic agent usage ) of previous studies done in our clinic and medical data base reviews.

Official Title
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Is Topical Antibiotic Prophylaxis Effective in Lichtenstein Hernia Repair: a Comparison Study

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Drug: Gentamicin and cefazolin
* Drug: Cefazolin
* Drug: Gentamicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of inguinal hernia Exclusion Criteria: Femoral hernia Emergency cases

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: gentamicin<br>80 mg gentamicin topical application intraoperatively | Drug: Gentamicin<br>* 80 mg gentamicin application intraoperatively<br>* Other names: Gentamed;|
| Active Comparator: Cefazolin<br>Application of 1000 mg cefazolin intra venously 1 hour before surgery | Drug: Cefazolin<br>* 1000 mg cefazolin application intravenously 1 hour before operation<br>* Other names: Eqizolin;|
| Active Comparator: gentamicin and cefazolin<br>1000 mg cefazolin application 1 hour before surgery and topical 80 mg gentamicin intraoperatively | Drug: Gentamicin and cefazolin<br>* 80 mg topically, intra-operative,single dose and intravenous 1000 mg cefazolin 1 hour before operation<br>* Other names: Gentamed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Post-operative Infection |  | within the first 30 days after surgery | 
| Number of Infections in Each Study Arm | Patients were examined on postoperative 30 days for the presence of surgical site infection. | within the 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inguinal hernia, infection prophylaxis, topical gentamicin