Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair

Diskapi Teaching and Research Hospital

Status and phase: Completed; Phase 4

Conditions: Inguinal Hernia

Treatments: Drug: Gentamicin; Drug: Gentamicin and cefazolin; Drug: Cefazolin

Study type: Interventional

Funder types: Other

Identifiers

NCT01273818

FC-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 276 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of inguinal hernia

Exclusion criteria

• Femoral hernia
• Emergency cases

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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276 participants in 3 patient groups

gentamicin

Active Comparator group

Description:

80 mg gentamicin topical application intraoperatively

Treatment:

Drug: Gentamicin

Cefazolin

Active Comparator group

Description:

Application of 1000 mg cefazolin intra venously 1 hour before surgery

Treatment:

Drug: Cefazolin

gentamicin and cefazolin

Active Comparator group

Description:

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

Treatment:

Drug: Gentamicin and cefazolin