Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duray Seker, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT01273818
First received: January 10, 2011
Last updated: December 17, 2014
Last verified: September 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: Yes ]
  • Number of Infections in Each Study Arm [ Time Frame: within the 30 days after surgery ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of inguinal hernia

Exclusion Criteria:

  • Femoral hernia
  • Emergency cases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273818

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

Publications:

Responsible Party: Duray Seker, M.D. Surgery, Diskapi Teaching and Research Hospital
ClinicalTrials.gov 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
Health Authority: Turkey: Ministry of Health

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

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Hernia, Abdominal
Pathological Conditions, Anatomical
Cefazolin
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015