Preventing wound infections in children having open groin surgery with IV antibiotics or antimicrobial-coated sutures
Intravenous Prophylactic Antibiotics and Antimicrobial-Coated Sutures in Preventing Surgical Site Infection in Open Paediatric Groin Surgeries: A 3-arm Randomized Controlled Trial
This will test whether a single IV antibiotic dose or antimicrobial-coated sutures prevent wound infections in children having open groin surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 174 (estimated) |
| Ages | N/A to 15 Years |
| Sex | All |
| Sponsor | Obafemi Awolowo University Teaching Hospital Academic / other |
| Locations | 1 site (Ile-Ife, Osun State) |
| Trial ID | NCT07346742 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ile-Ife, Osun State
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.