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Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair

This study has been completed.
Information provided by (Responsible Party):
Duray Seker, Diskapi Teaching and Research Hospital Identifier:
First received: January 10, 2011
Last updated: December 17, 2014
Last verified: September 2014
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.

Condition Intervention Phase
Inguinal Hernia
Drug: Gentamicin and cefazolin
Drug: Cefazolin
Drug: Gentamicin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Prevention
Official Title: Is Topical Antibiotic Prophylaxis Effective in Lichtenstein Hernia Repair: a Comparison Study

Resource links provided by NLM:

Further study details as provided by Diskapi Teaching and Research Hospital:

Primary Outcome Measures:
  • 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.

Enrollment: 276
Study Start Date: January 2011
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: gentamicin
80 mg gentamicin topical application intraoperatively
Drug: Gentamicin
80 mg gentamicin application intraoperatively
Other Names:
  • Gensif
  • Gentamed
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:
  • Cezal
  • Eqizolin
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:
  • Drug: Cefazolin
  • Other names:
  • Cezol
  • Eqizolin
  • Drug: Gentamicin
  • Gensif
  • Gentamed

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.


Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of inguinal hernia

Exclusion Criteria:

  • Femoral hernia
  • Emergency cases
  Contacts and Locations
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Please refer to this study by its identifier: NCT01273818

Diskapi Yildirim Beyazit Teaching and research Hospital
Ankara, Turkey, 06000
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
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
  More Information


Responsible Party: Duray Seker, M.D. Surgery, Diskapi Teaching and Research Hospital Identifier: NCT01273818     History of Changes
Other Study ID Numbers: FC-001
Study First Received: January 10, 2011
Results First Received: December 9, 2013
Last Updated: December 17, 2014

Keywords provided by Diskapi Teaching and Research Hospital:
inguinal hernia
infection prophylaxis
topical gentamicin

Additional relevant MeSH terms:
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 21, 2017