Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT01273818
First received: January 10, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  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
Gentamicin
Drug: Gentamicins+cephazolin sodium
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 ]

Secondary Outcome Measures:
  • Evidence of prophylactic antibiotic usage and it's type of application [ Time Frame: within the 30 days after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: gentamicin
Gentamicin arm: application of 80 mg gentamycin topically
Drug: Gentamicins+cephazolin sodium
80 mg topically, intra-operative,single dose
Other Name: gentamicin
Active Comparator: Cephazolin
Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery
Drug: Gentamicins+cephazolin sodium
80 mg topically, intra-operative,single dose
Other Name: gentamicin
Active Comparator: gentamicin+ cefazolin sodium
Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively
Drug: Gentamicins+cephazolin sodium
80 mg topically, intra-operative,single dose
Other Name: gentamicin

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+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
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: 4th General Surgery Clinic, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT01273818     History of Changes
Other Study ID Numbers: FC-001
Study First Received: January 10, 2011
Last Updated: January 10, 2011
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
Pathological Conditions, Anatomical
Hernia, Abdominal
Anti-Bacterial Agents
Cefazolin
Gentamicins
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014