Prevention of Surgical Site Infection in Open Paediatric Groin Surgeries Using Intravenous Prophylactic Antibiotics and Antimicrobial-coated Sutures

January 8, 2026 updated by: Olawumi Olajide

Intravenous Prophylactic Antibiotics and Antimicrobial-Coated Sutures in Preventing Surgical Site Infection in Open Paediatric Groin Surgeries: A 3-arm Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Nigeria
    • Osun State
      • Ile-Ife, Osun State, Nigeria, 220282
        • Recruiting
        • Obafemi Awolowo University Teaching Hospitals Complex
        • Contact:
        • Principal Investigator:
          • Olawumi Olajide, M.B.Ch.B

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: No Antibiotics arm
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
0.2ml of Vitamin Bco injection + 9.8ml sterile water
Active Comparator: Intravenous prophylactic antibiotic arm
Participants will have an intravenous prophylactic antibiotics given at the induction of anaesthesia and their wounds closed with non-coated sutures
Drug: Intravenous Cefuroxime
Intravenous cefuroxime is given at the induction of anaesthesia
Experimental: Antimicrobial-coated suture arm
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
Use of Antimicrobial-coated sutures to close all layers of the surgical wound following open paediatric groin surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Surgical site infection
Time Frame: 30 days post operative period
30 days post operative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Olawumi Olajide

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2025

Primary Completion (Estimated)

February 27, 2026

Study Completion (Estimated)

February 27, 2026

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERC/2024/08/11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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