Antibiotic Prophylaxis in Mesh Repair of Inguinal Hernias

December 20, 2010 updated by: Diskapi Teaching and Research Hospital

Single Dose Antibiotic Prophylaxis in Lihtenstein Repair for Primary Inguinal Hernias

Inguinal hernia repairs is clean surgical procedures. However infection may be a concern when prosthetic materials are used. This prospective randomized study has been set to observe if antibiotic prohylaxis is of benefit in mesh repair of inguinal hernias.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There are two group in the study. Control group received no antibiotic prohylaxis, whereas a single dose 1 gr. intravenous cefazoline is given to the patient in prophylaxis arm of the study. 30-days surgical site infection rates and 1 year prosthetic intervention late infection rates are observed and recorded. Side effects of antibiotic used are also recorded.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: inguinal hernia repair -

Exclusion Criteria: uncontrolled diabetes mellitus,

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Antibiotic prohylaxis / Lichtenstein repair
Drug: sefazolin
In prophylaxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Surgical site infection
Time Frame: 30 days postoperatively
30 days postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Drug side effects
Time Frame: 5 days postoperatively
5 days postoperatively
1-year prosthetic repair surgical site late infection rate
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Teaching and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

December 20, 2010

First Submitted That Met QC Criteria

December 20, 2010

First Posted (ESTIMATE)

December 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 21, 2010

Last Update Submitted That Met QC Criteria

December 20, 2010

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEAH-1002-IHR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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