Topical antibiotic use in elective inguinal hernia repair
| ISRCTN | ISRCTN25710082 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25710082 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/01/2010
- Registration date
- 13/04/2010
- Last edited
- 13/04/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
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
Dr Ipek Ozyaylali
Scientific
Scientific
Cukurambar mahallesi, 38.cd. 33/A
Ankara
06520
Türkiye
Study information
| Study design | Single centre 2 arm interventional study |
|---|---|
| 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 contact details below to request a patient information sheet (in Turkish) |
| Scientific title | Single dose intravenous antibiotic versus intravenous plus topical antibiotic prophylaxis in patients undergo elective unilateral inguinal hernia repair with polypropylene mesh. |
| Study objectives | Generally antibiotic prophylaxis is not recommended for pure suture-tissue repairs for inguinal hernias on elective basis. However, prophylaxis may be useful when prosthetic materials as a foreign body are used. Single dose intravenous antibiotic prophylaxis may overcome the problem, but some centres are still experiencing high surgical site infection rates. Recently topical antibiotic use in addition to intravenous single shot have been examined. Inguinal hernias consume a very big part of health resources. Surgical site infection, although not common, may increase that financial burden. Infection also is known to cause recurrence which is another element of further expenses. |
| Ethics approval(s) | The institution where the study will be done is a private centre with no ethical authority. The antibiotics to be used in the study are registered with the Turkish Health Authority. |
| Health condition(s) or problem(s) studied | Inguinal hernia |
| Intervention | 1. The routine prophylaxis group will receive single dose intravenous cephazolin. 2. The intervention group will also receive this shot. In addition, gentamycine will be used topically after the wound is irrigated with saline at the end of the repair before the subcutaneous tissue and the skin are closed. Duration of follow up will be 30 days for postoperative infection rate and 1 year for late foreign body infection rate. |
| Intervention type | Other |
| Primary outcome measure | 1. Surgical site infection 2. Superficial and deep infection rates All outcomes will be measured at postoperative days: 1, 3, 7 and 30 |
| Secondary outcome measures | 1. Features of the infection 2. Treatment of the infection 3. Microbial culture and antibiogram 4. Financial portrait of the infection All outcomes will be measured at postoperative days: 1, 3, 7 and 30 |
| Overall study start date | 01/02/2010 |
| Completion date | 01/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 in total, in 2 arms |
| Key inclusion criteria | 1. Primary unilateral inguinal hernia 2. Recurrent unilateral inguinal hernia 3. Elective repair 4. Male or female |
| Key exclusion criteria | Bilateral hernia repair |
| Date of first enrolment | 01/02/2010 |
| Date of final enrolment | 01/11/2010 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Cukurambar mahallesi, 38.cd. 33/A
Ankara
06520
Türkiye
06520
Türkiye
Sponsor information
Ankara Hernia Centre (Turkey)
Hospital/treatment centre
Hospital/treatment centre
Cukurambar mahallesi, 38.cd. 33/A
Ankara
06520
Türkiye
| Website | http://www.herniaturk.org |
|---|
Funders
Funder type
Hospital/treatment centre
Ankara Hernia Centre (Turkey)
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 |
