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Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01273818
First Posted: January 11, 2011
Last Update Posted: December 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Duray Seker, Diskapi Teaching and Research Hospital
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Duray Seker, 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.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Clinical diagnosis of inguinal hernia

Exclusion Criteria:

  • Femoral hernia
  • Emergency cases
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: January 10, 2011
First Posted: January 11, 2011
Results First Submitted: December 9, 2013
Results First Posted: December 29, 2014
Last Update Posted: December 29, 2014
Last Verified: September 2014

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

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