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ISRCTN
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ISRCTN85660082
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ClinicalTrials.gov identifier
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Public title
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The possible benefit of prophylactic antibiotic use in patients undergoing unilateral elective inguinal hernia repair with prosthetic material.
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Scientific title
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Prospective randomized controlled trial on the use of single dose antibiotic prophylaxis in patients undergo unilateral elective primary inguinal hernia repair with standard polypropylene mesh.
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Tension-free repairs with prosthetic materials has lowered the recurrence rates in inguinal hernia repairs. As a foreign material polypropylene mesh may increase surgical site infection rate in early and late period. Some prospective randomised studies were done in this subject to reveal the benefit of antibiotic prophylaxis in these operations. However, no consensus does exist and every institution runs its own protocol to manage the cases.
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Lay summary
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Ethics approval
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Diskapi Teaching and Research Hospital Ethics Committee approved on the 24th of June 2009 (ref: 0016)
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Study design
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Prospective interventional double blind randomised active controlled trial.
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Countries of recruitment
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Turkey
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Disease/condition/study domain
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inguinal hernia; surgical site infection; wound infection
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Participants - inclusion criteria
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1. Patients with primary unilateral hernia
2. Patients undergo unilateral primary hernia repair with a previously repaired or leave for interval repair on the contralateral side.
3. Age greater than 18 years, both female and male
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Participants - exclusion criteria
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1. Patients undergo simultaneous bilateral hernia repair
2. Patients with newly diagnosed or uncontrolled diabetes mellitus
3. Patients who do not accept the registry and randomisation
4. Incarcerated or strangulated hernias requiring emergency repair
5. Known severe coagulation disorder
6. Patients who use aspirin, clopidogrel (Plavix®) or warfarin (Coumadin®)
7. Recurrent hernias
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Anticipated start date
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01/07/2009
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Anticipated end date
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30/06/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet. (in Turkish)
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Target number of participants
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200
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Interventions
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Eligible patients will be randomised by using sealed envelopes (equally numbered) to the control arm (no antibiotic prophylaxis) or to the intervention arm (antibiotic prophylaxis). The patients in the intervention arm will receive single dose intravenous cefazolin at the induction of anaesthesia. No topical antibiotic or antiseptic agents will be used within the surgical field after the repair is completed. No patients in either group will be given any additional antibiotic postoperatively. Dressings put in the operation room will be changed on day 1 and totally removed on day 3. Control examination for infection follow-up will take place on day 1, day 3, day 7 and day 30. The late surgical site infection rates will be measured after one postoperative year for each patient and will be announced in a further report.
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Primary outcome measure(s)
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Surgical site infection:
1. Superficial infection
2. Deep infection
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Secondary outcome measure(s)
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Components of the primary outcome:
1. Day of infection first recognised
2. Microbial culture for identification of the microorganism
3. Therapeutic antibiotic regimen according to antibiogram results
4. Final result for the wound and prosthetic material
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Sources of funding
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Diskapi Teaching and Research Hospital (Turkey) - Department of Surgery
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Trial website
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Publications
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Contact name
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Prof
Hakan
Kulacoglu
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Address
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Bahcelievler, 1.cadde, 109/5
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City/town
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Ankara
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Zip/Postcode
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06490
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Country
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Turkey
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Email
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hakankulacoglu@hotmail.com
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Sponsor
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Diskapi Teaching and Research Hospital (Turkey)
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Address
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c/o Hakan Kulacoglu, MD, FACS,
Associate Professor of Surgery
Department of Surgery
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City/town
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Ankara
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Zip/Postcode
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06000
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Country
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Turkey
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Email
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hakankulacoglu@hotmail.com
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Sponsor website:
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http://www.diskapieah.gov.tr/english.htm
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Date applied
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21/01/2010
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Last edited
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04/03/2010
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Date ISRCTN assigned
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04/03/2010
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