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Antibiotic Prophylaxis in Mesh Repair of Inguinal Hernias

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ClinicalTrials.gov Identifier: NCT01264003
Recruitment Status : Completed
First Posted : December 21, 2010
Last Update Posted : December 21, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Drug: sefazolin Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
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
Study Start Date : May 2008
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Hernia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Antibiotic prohylaxis / Lichtenstein repair
Drug: sefazolin
In prophylaxis


Outcome Measures

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

Secondary Outcome Measures :
  1. Drug side effects [ Time Frame: 5 days postoperatively ]
  2. 1-year prosthetic repair surgical site late infection rate [ Time Frame: 1 year ]

Eligibility Criteria

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,

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 Posted: December 21, 2010    Key Record Dates
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