Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-03-31

Brief Summary

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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

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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.

Conditions

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Inguinal Hernia

Keywords

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inguinal hernia infection prophylaxis topical gentamicin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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gentamicin

80 mg gentamicin topical application intraoperatively

Group Type ACTIVE_COMPARATOR

Gentamicin

Intervention Type DRUG

80 mg gentamicin application intraoperatively

Cefazolin

Application of 1000 mg cefazolin intra venously 1 hour before surgery

Group Type ACTIVE_COMPARATOR

Cefazolin

Intervention Type DRUG

1000 mg cefazolin application intravenously 1 hour before operation

gentamicin and cefazolin

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

Group Type ACTIVE_COMPARATOR

Gentamicin and cefazolin

Intervention Type DRUG

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

Interventions

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Gentamicin and cefazolin

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

Intervention Type DRUG

Cefazolin

1000 mg cefazolin application intravenously 1 hour before operation

Intervention Type DRUG

Gentamicin

80 mg gentamicin application intraoperatively

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of inguinal hernia

Exclusion Criteria

* Femoral hernia
* Emergency cases

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Duray Seker

M.D. Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR