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OpenTrials
Completed

NCT Number: NCT01273818

Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair

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.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Diskapi Yildirim Beyazit Teaching and research Hospital

Ankara, 06000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of inguinal hernia

Exclusion criteria

  • Femoral hernia
  • Emergency cases

Treatment and study plan

Gentamicin and cefazolin

Drug

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

Cefazolin

Drug

1000 mg cefazolin application intravenously 1 hour before operation

Other names: Cezal, Eqizolin

Gentamicin

Drug

80 mg gentamicin application intraoperatively

Other names: Gensif, Gentamed

Primary outcomes

  1. Rate of Post-operative Infection

    Time frame: within the first 30 days after surgery

  2. 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.

Sponsors and collaborators

Lead sponsor

Diskapi Teaching and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 11, 2011
Registry last updated
Dec 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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