RecruitingNot ApplicableNCT07346742

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


Sponsor

Olawumi Olajide

Enrollment

174 participants

Start Date

Mar 9, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 15 Years

Inclusion Criteria1

  • All patients with clinical conditions requiring daycase open groin surgery

Exclusion Criteria5

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

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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

OTHERPlacebo intravenous injection

0.2ml of Vitamin Bco injection + 9.8ml sterile water


Locations(1)

Obafemi Awolowo University Teaching Hospitals Complex

Ile-Ife, Osun State, Nigeria

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NCT07346742


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