Antibiotic Prophylaxis in Mesh Repair of Inguinal Hernias

This study has been completed.
Sponsor:
Information provided by:
Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT01264003
First received: December 20, 2010
Last updated: NA
Last verified: May 2008
History: No changes posted

December 20, 2010
December 20, 2010
May 2008
December 2010   (final data collection date for primary outcome measure)
Surgical site infection [ Time Frame: 30 days postoperatively ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Drug side effects [ Time Frame: 5 days postoperatively ] [ Designated as safety issue: Yes ]
  • 1-year prosthetic repair surgical site late infection rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Antibiotic Prophylaxis in Mesh Repair of Inguinal Hernias
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Inguinal Hernia
Drug: sefazolin
In prophylaxis
Active Comparator: 1
Antibiotic prohylaxis / Lichtenstein repair
Intervention: Drug: sefazolin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria: inguinal hernia repair -

Exclusion Criteria: uncontrolled diabetes mellitus,

-

Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01264003
DEAH-1002-IHR
No
4.Cerrahi Kliniği, Diskapi Teaching and Research Hospital
Diskapi Teaching and Research Hospital
Not Provided
Not Provided
Diskapi Teaching and Research Hospital
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP