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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07346742
Enrollment
174
Registered
2026-01-16
Start date
2025-03-09
Completion date
2026-02-27
Last updated
2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydroceles, Inguinal Hernia, Surgical Site Infection

Keywords

Paediatric groin surgeries, Intravenous prophylactic antibiotics, Antimicrobial-coated sutures, Double blinded randomized controlled trial

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.

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.

Interventions

DEVICEAntimicrobial-coated sutures

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

DRUGIntravenous Cefuroxime

Intravenous cefuroxime is given at the induction of anaesthesia

0.2ml of Vitamin Bco injection + 9.8ml sterile water

Sponsors

Olawumi Olajide
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Surgical site infection30 days post operative period

Countries

Nigeria

Contacts

CONTACTOlawumi Olajide, M.B.Ch.B
yejola1212@gmail.com+2348038696179

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026