NCT07346742

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2026

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

January 8, 2026

Last Update Submit

January 8, 2026

Conditions

Inguinal HerniaSurgical Site InfectionHydroceles

Keywords

Paediatric groin surgeriesIntravenous prophylactic antibioticsAntimicrobial-coated suturesDouble blinded randomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Surgical site infection

    30 days post operative period

Study Arms (3)

No Antibiotics arm

PLACEBO COMPARATOR

Participants will have intravenous placebo injection given at the induction of anaesthesia and their surgical wounds closed using non-coated sutures

Other: Placebo intravenous injection

Intravenous prophylactic antibiotic arm

ACTIVE COMPARATOR

Participants will have an intravenous prophylactic antibiotics given at the induction of anaesthesia and their wounds closed with non-coated sutures

Drug: Intravenous Cefuroxime

Antimicrobial-coated suture arm

EXPERIMENTAL

Participants will have an intravenous placebo injection given at the induction of anaesthesia and their wounds closed with antimicrobial-coated sutures

Device: Antimicrobial-coated sutures

Interventions

Antimicrobial-coated suturesDEVICE

Use of Antimicrobial-coated sutures to close all layers of the surgical wound following open paediatric groin surgery

Antimicrobial-coated suture arm
Intravenous CefuroximeDRUG

Intravenous cefuroxime is given at the induction of anaesthesia

Intravenous prophylactic antibiotic arm
Placebo intravenous injectionOTHER

0.2ml of Vitamin Bco injection + 9.8ml sterile water

No Antibiotics arm

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All patients with clinical conditions requiring daycase open groin surgery

You may not qualify if:

  • Re-operations
  • Immunocompromised patients
  • Malnourished patients
  • Complicated groin pathologies e,g obstructed inguinal hernia
  • History of antibiotic usage in the last seven days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obafemi Awolowo University Teaching Hospitals Complex

Ile-Ife, Osun State, 220282, Nigeria

RECRUITING

MeSH Terms

Conditions

Hernia, InguinalSurgical Wound Infection

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsWound InfectionInfectionsPostoperative ComplicationsPathologic Processes

Central Study Contacts

Olawumi Olajide, M.B.Ch.B

CONTACT

+2348038696179yejola1212@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Registrar

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 16, 2026

Study Start

March 9, 2025

Primary Completion

February 27, 2026

Study Completion

February 27, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

NG(1)