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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: inguinal hernia repair -

Exclusion Criteria: uncontrolled diabetes mellitus,

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: 4.Cerrahi Kliniği, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT01264003     History of Changes
Other Study ID Numbers: DEAH-1002-IHR
Study First Received: December 20, 2010
Last Updated: December 20, 2010
Health Authority: Turkey: Ministry of Health

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
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on October 19, 2014