Preventing wound infections in children having open groin surgery with IV antibiotics or antimicrobial-coated sutures
Official title: Intravenous Prophylactic Antibiotics and Antimicrobial-Coated Sutures in Preventing Surgical Site Infection in Open Paediatric Groin Surgeries: A 3-arm Randomized Controlled Trial
Run by Obafemi Awolowo University Teaching Hospital · NCT07346742 · Data updated 2026-11-12
This will test whether a single IV antibiotic dose or antimicrobial-coated sutures prevent wound infections in children having open groin surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 15 Years |
| Sex | All |
| Enrollment | 174 (estimated) |
| Sponsor | Obafemi Awolowo University Teaching Hospital Academic / other |
| Locations | 1 site (Ile-Ife, Osun State) |
| Status | Recruiting |
| Started | March 9, 2025 |
| Main results expected | February 27, 2026 |
| Study ends | February 27, 2026 |
| Registry record updated | January 16, 2026 |
| Trial ID | NCT07346742 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children requiring daycase open groin surgery (inguinal hernia or hydrocele) who are not immunocompromised, not malnourished, not undergoing re-operation, have no complicated groin pathology, and have not used antibiotics in the prior seven days.
✕Probably not a fit
Patients who are immunocompromised, malnourished, undergoing re-operation, with complicated groin pathology, or who recently used antibiotics are excluded and unlikely to benefit from this trial's results.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a double-blinded, randomized three-arm trial enrolling children scheduled for daycase open groin surgery (inguinal hernia or hydrocele) at a single tertiary hospital. On the morning of surgery participants are randomly assigned to receive IV cefuroxime or placebo and to have wounds closed with either antimicrobial-coated or standard sutures, creating comparison groups for no antibiotic, IV antibiotic, and coated-suture strategies. Surgical site infection will be recorded at postoperative visits on days 5, 13, and 30 using predefined clinical criteria. The trial compares infection rates between the groups to see which intervention, if any, reduces postoperative wound infections.
Why it matters
Potential benefit: If successful, the interventions could lower postoperative wound infection rates, reduce complications and repeat care, and inform antibiotic and suture choices for pediatric groin surgery.
How similar studies have gone: Evidence from broader surgical literature shows antimicrobial-coated sutures can modestly reduce surgical site infections and data on routine prophylactic antibiotics for clean pediatric groin repairs are mixed, so this trial combines a somewhat supported and a debated approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients with clinical conditions requiring daycase open groin surgery Exclusion Criteria: 1. Re-operations 2. Immunocompromised patients 3. Malnourished patients 4. Complicated groin pathologies e,g obstructed inguinal hernia 5. History of antibiotic usage in the last seven days
Where it's running
-
Obafemi Awolowo University Teaching Hospitals Complex
Ile-Ife, Osun State, Nigeria Recruiting
Study contacts
- Study coordinator: Olawumi Olajide, M.B.Ch.B
- Email: yejola1212@gmail.com
- Phone: +2348038696179
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.