Condition category
Infections and Infestations
Date applied
21/01/2010
Date assigned
04/03/2010
Last edited
04/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hakan Kulacoglu

ORCID ID

Contact details

Bahcelievler
1.cadde
109/5
Ankara
06490
Turkey
hakankulacoglu@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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.

Acronym

Study hypothesis

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.

Ethics approval

Diskapi Teaching and Research Hospital Ethics Committee approved on the 24th of June 2009 (ref: 0016)

Study design

Prospective interventional double blind randomised active controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet. (in Turkish)

Condition

inguinal hernia; surgical site infection; wound infection

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Surgical site infection:
1. Superficial infection
2. Deep infection

Secondary outcome measures

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

Overall trial start date

01/07/2009

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

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

Recruitment start date

01/07/2009

Recruitment end date

30/06/2010

Locations

Countries of recruitment

Turkey

Trial participating centre

Bahcelievler, 1.cadde, 109/5
Ankara
06490
Turkey

Sponsor information

Organisation

Diskapi Teaching and Research Hospital (Turkey)

Sponsor details

c/o Hakan Kulacoglu
MD
FACS
Associate Professor of Surgery
Department of Surgery
Ankara
06000
Turkey
hakankulacoglu@hotmail.com

Sponsor type

Hospital/treatment centre

Website

http://www.diskapieah.gov.tr/english.htm

Funders

Funder type

Hospital/treatment centre

Funder name

Diskapi Teaching and Research Hospital (Turkey) - Department of Surgery

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes