Viewing Study NCT01264003


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Study NCT ID: NCT01264003
Status: COMPLETED
Last Update Posted: 2010-12-21
First Post: 2010-12-20
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Antibiotic Prophylaxis in Mesh Repair of Inguinal Hernias
Sponsor: Diskapi Teaching and Research Hospital
Organization:

Study Overview

Official Title: Single Dose Antibiotic Prophylaxis in Lihtenstein Repair for Primary Inguinal Hernias
Status: COMPLETED
Status Verified Date: 2008-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: