Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair

Phase 4

Completed

• Conditions: Inguinal Hernia
• Interventions: Drug: Cefazolin; Drug: Gentamicin and cefazolin; Drug: Gentamicin

• Registration Number: NCT01273818
• Lead Sponsor: Diskapi Teaching and Research Hospital

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-10
• Study First Posted: 2011-01-11
• Primary Completion: 2013-02
• Study Completion: 2013-03
• Results First Submitted: 2013-12-09
• Status Verified: 2014-09
• Results First Submitted QC: 2014-12-17
• Last Update Submitted: 2014-12-17
• Results First Posted: 2014-12-29
• Last Update Posted: 2014-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

• Clinical diagnosis of inguinal hernia

Exclusion Criteria

• Femoral hernia
• Emergency cases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cefazolin	Cefazolin	Application of 1000 mg cefazolin intra venously 1 hour before surgery
gentamicin and cefazolin	Gentamicin and cefazolin	1000 mg cefazolin application 1 hour before surgery and topical 80 mg gentamicin intraoperatively
gentamicin	Gentamicin	80 mg gentamicin topical application intraoperatively

Primary Outcome Measures

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

Trial Locations

Locations (1)

Diskapi Yildirim Beyazit Teaching and research Hospital; 🇹🇷 Ankara, Turkey