Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair

December 17, 2014 updated by: Duray Seker, Diskapi Teaching and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

276

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06000
        • Diskapi Yildirim Beyazit Teaching and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of inguinal hernia

Exclusion Criteria:

  • Femoral hernia
  • Emergency cases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: gentamicin
80 mg gentamicin topical application intraoperatively
Drug: Gentamicin
80 mg gentamicin application intraoperatively
Other Names:
  • Gentamed
  • Gensif
Active Comparator: Cefazolin
Application of 1000 mg cefazolin intra venously 1 hour before surgery
Drug: Cefazolin
1000 mg cefazolin application intravenously 1 hour before operation
Other Names:
  • Eqizolin
  • Cezal
Active Comparator: gentamicin and cefazolin
1000 mg cefazolin application 1 hour before surgery and topical 80 mg gentamicin intraoperatively
Drug: Gentamicin and cefazolin
80 mg topically, intra-operative,single dose and intravenous 1000 mg cefazolin 1 hour before operation
Other Names:
  • Gentamed
  • Other names:
  • Drug: Cefazolin
  • Cezol
  • Eqizolin
  • Drug: Gentamicin
  • Gensif

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Post-operative Infection
Time Frame: within the first 30 days after surgery
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.
within the 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Teaching and Research Hospital

Investigators

  • Principal Investigator: Gaye E Seker, MD, Diskapi Yildirim Beyazit Teaching and Research Hospital
  • Study Director: Duray Seker, MD, Diskapi Yildirim Beyazit Teaching and Research Hospital
  • Study Chair: Bahattin Bayar, MD, Diskapi Yildirim Beyazit Teaching and Research Hospital
  • Study Chair: Zafer Ergul, MD, Diskapi Yildirim Beyazit Teaching and Research Hospital
  • Study Chair: Hakan Kulacoglu, Professor, Diskapi Yildirim Beyazit Teaching and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 10, 2011

First Submitted That Met QC Criteria

January 10, 2011

First Posted (Estimate)

January 11, 2011

Study Record Updates

Last Update Posted (Estimate)

December 29, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FC-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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