Recruiting

Preventing Surgical Site Infection in Paediatric Groin Surgeries: Intravenous Prophylactic Antibiotics and Antimicrobial-Coated Sutures

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Study Aim

This study aims to prevent surgical site infections in children undergoing groin surgeries by using intravenous prophylactic antibiotics and antimicrobial-coated sutures.

What is being tested

Antimicrobial-coated sutures

+ Intravenous Cefuroxime

+ Placebo intravenous injection

DeviceDrugOther
Who is being recruted

Hernia+7

+ Hernia, Inguinal

+ Infections

Until 15 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: March 2025
See protocol details

Summary

Principal SponsorOlawumi Olajide
Study ContactOlawumi Olajide, M.B.Ch.B
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 9, 2025

Actual date on which the first participant was enrolled.

This clinical trial aims to find out if using intravenous prophylactic antibiotics and antimicrobial-coated sutures can help prevent surgical site infections in children who are having open groin surgeries. The study is important because it could help improve care and reduce the risk of infections for children undergoing these types of surgeries. The trial will compare the rate of surgical site infections in surgeries without antibiotics, with the use of intravenous prophylactic antibiotics, and with the use of antimicrobial-coated sutures. Participants in this study will be randomly assigned to one of three groups on the morning of their surgery. Those in group A will receive an intravenous placebo injection at the start of anesthesia and their surgical wounds will be closed using non-coated sutures. Participants in group B will receive an intravenous prophylactic antibiotic at the start of anesthesia and their surgical wounds will also be closed using non-coated sutures. Those in group C will receive an intravenous placebo injection at the start of anesthesia and their surgical wounds will be closed using antimicrobial-coated sutures. All participants will visit the clinic on postoperative days 5, 13, and 30 for a review of their surgical wounds to check for any signs of infection following the CDC guidelines.

Official TitleIntravenous Prophylactic Antibiotics and Antimicrobial-Coated Sutures in Preventing Surgical Site Infection in Open Paediatric Groin Surgeries: A 3-arm Randomized Controlled Trial
Principal SponsorOlawumi Olajide
Study ContactOlawumi Olajide, M.B.Ch.B
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

174 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 15 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HerniaHernia, InguinalInfectionsPathologic ProcessesPostoperative ComplicationsSurgical Wound InfectionPathological Conditions, Signs and SymptomsWound InfectionPathological Conditions, AnatomicalHernia, Abdominal

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Group III

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Obafemi Awolowo University Teaching Hospitals Complex

Ile-Ife, NigeriaOpen Obafemi Awolowo University Teaching Hospitals Complex in Google Maps
Recruiting
One Study Center