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Antibiotic Prophylaxis in Mesh Repair of Inguinal Hernias

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01264003
First Posted: December 21, 2010
Last Update Posted: December 21, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Diskapi Teaching and Research Hospital
December 20, 2010
December 21, 2010
December 21, 2010
May 2008
December 2010   (Final data collection date for primary outcome measure)
Surgical site infection [ Time Frame: 30 days postoperatively ]
Same as current
No Changes Posted
  • Drug side effects [ Time Frame: 5 days postoperatively ]
  • 1-year prosthetic repair surgical site late infection rate [ Time Frame: 1 year ]
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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,

Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01264003
DEAH-1002-IHR
No
Not Provided
Not Provided
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