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Antibiotic Prophylaxis in Mesh Repair of Inguinal Hernias

Primary Purpose

Inguinal Hernia

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

sefazolin

About this trial

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

Eligibility Criteria

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

Inclusion Criteria: inguinal hernia repair -

Exclusion Criteria: uncontrolled diabetes mellitus,

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Arm Description

Antibiotic prohylaxis / Lichtenstein repair

Outcomes

Primary Outcome Measures

Surgical site infection

Secondary Outcome Measures

Drug side effects

1-year prosthetic repair surgical site late infection rate

Full Information

NCT ID

NCT01264003

First Posted

December 20, 2010

Last Updated

December 20, 2010

Sponsor

Diskapi Teaching and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01264003

Brief Title

Antibiotic Prophylaxis in Mesh Repair of Inguinal Hernias

Official Title

Single Dose Antibiotic Prophylaxis in Lihtenstein Repair for Primary Inguinal Hernias

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Diskapi Teaching and Research Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

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

Inguinal Hernia

Keywords

inguinal hernia, antibiotic, prophylaxis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Antibiotic prohylaxis / Lichtenstein repair

Intervention Type

Drug

Intervention Name(s)

sefazolin

Intervention Description

In prophylaxis

Primary Outcome Measure Information:

Title

Surgical site infection

Time Frame

30 days postoperatively

Secondary Outcome Measure Information:

Title

Drug side effects

Time Frame

5 days postoperatively

Title

1-year prosthetic repair surgical site late infection rate

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: inguinal hernia repair - Exclusion Criteria: uncontrolled diabetes mellitus, -

12. IPD Sharing Statement

Learn more about this trial

Antibiotic Prophylaxis in Mesh Repair of Inguinal Hernias

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