Antibiotic Prophylaxis in Mesh Repair of Inguinal Hernias

Inguinal Hernia Clinical Trial

Official title:

Single Dose Antibiotic Prophylaxis in Lihtenstein Repair for Primary Inguinal Hernias

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264003
• Other study ID #: DEAH-1002-IHR
• Status: Completed
• Phase: Phase 4
• First received: December 20, 2010
• Last updated: December 20, 2010
• Start date: May 2008
• Est. completion date: December 2010

Study information

• Verified date: May 2008
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria: inguinal hernia repair -

Exclusion Criteria: uncontrolled diabetes mellitus,

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Drug:
• sefazolin
In prophylaxis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection		30 days postoperatively	No
Secondary	Drug side effects		5 days postoperatively	Yes
Secondary	1-year prosthetic repair surgical site late infection rate		1 year	No