Is Topical Antibiotic Prophylaxis Effective in Lichtenstein Hernia Repair: a Comparison Study
Overview
- Phase
- Phase 4
- Intervention
- Gentamicin
- Conditions
- Inguinal Hernia
- Sponsor
- Diskapi Teaching and Research Hospital
- Enrollment
- 276
- Locations
- 1
- Primary Endpoint
- Rate of Post-operative Infection
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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
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.
Investigators
Duray Seker
M.D. Surgery
Diskapi Teaching and Research Hospital
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of inguinal hernia
Exclusion Criteria
- •Femoral hernia
- •Emergency cases
Arms & Interventions
gentamicin
80 mg gentamicin topical application intraoperatively
Intervention: Gentamicin
Cefazolin
Application of 1000 mg cefazolin intra venously 1 hour before surgery
Intervention: Cefazolin
gentamicin and cefazolin
1000 mg cefazolin application 1 hour before surgery and topical 80 mg gentamicin intraoperatively
Intervention: Gentamicin and cefazolin
Outcomes
Primary Outcomes
Rate of Post-operative Infection
Time Frame: within the first 30 days after surgery
Number of Infections in Each Study Arm
Time Frame: within the 30 days after surgery
Patients were examined on postoperative 30 days for the presence of surgical site infection.