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Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair

Primary Purpose

Inguinal Hernia

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Gentamicin and cefazolin

Cefazolin

Gentamicin

About this trial

This is an interventional prevention trial for Inguinal Hernia focused on measuring inguinal hernia, infection prophylaxis, topical gentamicin

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical diagnosis of inguinal hernia

Exclusion Criteria:

Femoral hernia
Emergency cases

Sites / Locations

Diskapi Yildirim Beyazit Teaching and research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

gentamicin

Cefazolin

gentamicin and cefazolin

Arm Description

80 mg gentamicin topical application intraoperatively

Application of 1000 mg cefazolin intra venously 1 hour before surgery

1000 mg cefazolin application 1 hour before surgery and topical 80 mg gentamicin intraoperatively

Outcomes

Primary Outcome Measures

Rate of Post-operative Infection

Number of Infections in Each Study Arm

Patients were examined on postoperative 30 days for the presence of surgical site infection.

Secondary Outcome Measures

Full Information

NCT ID

NCT01273818

First Posted

January 10, 2011

Last Updated

December 17, 2014

Sponsor

Diskapi Teaching and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01273818

Brief Title

Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Diskapi Teaching and Research Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inguinal Hernia

Keywords

inguinal hernia, infection prophylaxis, topical gentamicin

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

276 (Actual)

8. Arms, Groups, and Interventions

Arm Title

gentamicin

Arm Type

Active Comparator

Arm Description

80 mg gentamicin topical application intraoperatively

Arm Title

Cefazolin

Arm Type

Active Comparator

Arm Description

Application of 1000 mg cefazolin intra venously 1 hour before surgery

Arm Title

gentamicin and cefazolin

Arm Type

Active Comparator

Arm Description

1000 mg cefazolin application 1 hour before surgery and topical 80 mg gentamicin intraoperatively

Intervention Type

Drug

Intervention Name(s)

Gentamicin and cefazolin

Other Intervention Name(s)

Drug: Cefazolin, Other names:, Cezol, Eqizolin, Drug: Gentamicin, Gensif, Gentamed

Intervention Description

80 mg topically, intra-operative,single dose and intravenous 1000 mg cefazolin 1 hour before operation

Intervention Type

Drug

Intervention Name(s)

Cefazolin

Other Intervention Name(s)

Cezal, Eqizolin

Intervention Description

1000 mg cefazolin application intravenously 1 hour before operation

Intervention Type

Drug

Intervention Name(s)

Gentamicin

Other Intervention Name(s)

Gensif, Gentamed

Intervention Description

80 mg gentamicin application intraoperatively

Primary Outcome Measure Information:

Title

Rate of Post-operative Infection

Time Frame

within the first 30 days after surgery

Title

Number of Infections in Each Study Arm

Description

Patients were examined on postoperative 30 days for the presence of surgical site infection.

Time Frame

within the 30 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of inguinal hernia Exclusion Criteria: Femoral hernia Emergency cases

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gaye E Seker, MD

Organizational Affiliation