Topical antibiotic use in elective inguinal hernia repair

ISRCTN	ISRCTN25710082
DOI	https://doi.org/10.1186/ISRCTN25710082
Protocol serial number	N/A
Sponsor	Ankara Hernia Centre (Turkey)
Funder	Ankara Hernia Centre (Turkey)

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

Cukurambar mahallesi, 38.cd. 33/A
Ankara
06520
Türkiye

Study information

Primary study design	Interventional
Study design	Single centre 2 arm interventional study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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(s)	1. Surgical site infection 2. Superficial and deep infection rates All outcomes will be measured at postoperative days: 1, 3, 7 and 30
Key secondary outcome measure(s)	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
Completion date	01/11/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes