The possible benefit of prophylactic antibiotic use in patients undergoing unilateral elective inguinal hernia repair with prosthetic material.
| ISRCTN | ISRCTN85660082 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85660082 |
| Secondary identifying numbers | N/A |
- Submission date
- 21/01/2010
- Registration date
- 04/03/2010
- Last edited
- 04/03/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Hakan Kulacoglu
Scientific
Scientific
Bahcelievler, 1.cadde, 109/5
Ankara
06490
Türkiye
| hakankulacoglu@hotmail.com |
Study information
| Study design | Prospective interventional double blind randomised active controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. (in Turkish) |
| 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. |
| Study objectives | 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(s) | Diskapi Teaching and Research Hospital Ethics Committee approved on the 24th of June 2009 (ref: 0016) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/07/2009 |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2009 |
| Date of final enrolment | 30/06/2010 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Bahcelievler, 1.cadde, 109/5
Ankara
06490
Türkiye
06490
Türkiye
Sponsor information
Diskapi Teaching and Research Hospital (Turkey)
Hospital/treatment centre
Hospital/treatment centre
c/o Hakan Kulacoglu, MD, FACS
Associate Professor of Surgery
Department of Surgery
Ankara
06000
Türkiye
| hakankulacoglu@hotmail.com | |
| Website | http://www.diskapieah.gov.tr/english.htm |
"ROR" |
https://ror.org/04bghze60 |
Funders
Funder type
Hospital/treatment centre
Diskapi Teaching and Research Hospital (Turkey) - Department of Surgery
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
