NCT07346742

Prevention of Surgical Site Infection in Open Paediatric Groin Surgeries Using Intravenous Prophylactic Antibiotics and 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Olawumi Olajide · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if the use of prophylactic antibiotics and antimicrobial-coated sutures can prevent surgical site infection in children undergoing open groin surgeries. The main question it aims to answer is: • Does the use of intravenous prophylactic antibiotics or antimicrobial-coated sutures significantly reduce the occurrence of surgical site infection in children undergoing open groin surgeries? Researchers will compare no antibiotic use to the use of intravenous prophylactic antibiotics, or antimicrobial-coated sutures to see if the use of intravenous prophylactic antibiotics and antimicrobial-coated sutures significantly reduces the occurrence of surgical site infection following open groin surgeries in children. Participants will: * Undergo open groin surgery with either the use of intravenous prophylactic antibiotic or antimicrobial-coated sutures or without antibiotic use * Visit the clinic on postoperative days 5, 13 and 30 for review of the surgical wounds for any sign of infection.

Detailed description

The aim of this clinical trial is to learn if the use of intravenous prophylactic antibiotics and antimicrobial-coated sutures can prevent surgical site infection in children undergoing open groin surgeries. The specific objectives are: * To determine the rate of surgical site infection in paediatric groin surgeries without antibiotics * To determine the rate of surgical site infection in paediatric groin surgeries with the use of intravenous prophylactic antibiotics * To determine the rate of surgical site infection in paediatric groin surgeries with the use of antimicrobial-coated sutures. * To compare the rates of surgical site infection in paediatric groin surgeries without antibiotics, with the use of intravenous prophylactic antibiotics and use of antimicrobial-coated sutures Researchers will compare no antibiotic use to the use of intravenous prophylactic antibiotics, or antimicrobial-coated sutures to see if the use of intravenous prophylactic antibiotics and antimicrobial-coated sutures significantly reduces the occurrence of surgical site infection following open groin surgeries in children. It shall be a double blinded randomized controlled trial Eligible Participants will: * On the morning of the surgery be randomly assigned to either group A or B or C * Participants in group A will have intravenous placebo injection given at the induction of anaesthesia and their surgical wounds closed using non-coated sutures * Participants in group B will have intravenous prophylactic antibiotic given at the induction of anaesthesia and their surgical wounds closed using non-coated sutures * Participants in group C will have intravenous placebo injection given at the induction of anaesthesia and their surgical wounds closed using antimicrobial-coated sutures * Visit the clinic on postoperative days 5, 13 and 30 for review of the surgical wounds for any sign of infection following the CDC guidelines.

Conditions

• Inguinal Hernia
• Hydroceles
• Surgical Site Infection

Interventions

Type	Name	Description
DEVICE	Antimicrobial-coated sutures	Use of Antimicrobial-coated sutures to close all layers of the surgical wound following open paediatric groin surgery
DRUG	Intravenous Cefuroxime	Intravenous cefuroxime is given at the induction of anaesthesia
OTHER	Placebo intravenous injection	0.2ml of Vitamin Bco injection + 9.8ml sterile water

Timeline

• Start date: 2025-03-09
• Primary completion: 2026-02-27
• Completion: 2026-02-27
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: Nigeria