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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
  Purpose
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.

Condition Intervention Phase
Inguinal Hernia Drug: sefazolin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Single Dose Antibiotic Prophylaxis in Lihtenstein Repair for Primary Inguinal Hernias

Resource links provided by NLM:


Further study details as provided by Diskapi Teaching and Research Hospital:

Primary Outcome Measures:
  • Surgical site infection [ Time Frame: 30 days postoperatively ]

Secondary Outcome Measures:
  • Drug side effects [ Time Frame: 5 days postoperatively ]
  • 1-year prosthetic repair surgical site late infection rate [ Time Frame: 1 year ]

Enrollment: 200
Study Start Date: May 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Antibiotic prohylaxis / Lichtenstein repair
Drug: sefazolin
In prophylaxis

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: inguinal hernia repair -

Exclusion Criteria: uncontrolled diabetes mellitus,

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: 4.Cerrahi Kliniği, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT01264003     History of Changes
Other Study ID Numbers: DEAH-1002-IHR
First Submitted: December 20, 2010
First Posted: December 21, 2010
Last Update Posted: December 21, 2010
Last Verified: May 2008

Keywords provided by Diskapi Teaching and Research Hospital:
inguinal hernia, antibiotic, prophylaxis

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents