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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 15
SponsorOlawumi Olajide

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients with clinical conditions requiring daycase open groin surgery

Disqualifiers

Re-operations

Immunocompromised patients

Malnourished patients

Complicated groin pathologies e,g obstructed inguinal hernia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Antimicrobial-coated sutures

    Device

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

  • Intravenous Cefuroxime

    Drug

    Intravenous cefuroxime is given at the induction of anaesthesia

  • Placebo intravenous injection

    Other intervention

    0.2ml of Vitamin Bco injection + 9.8ml sterile water

Treatment groups

174 Participants
are divided into 3 treatment groups
Group A: No Antibiotics armPlacebo comparator 1 intervention
Group B: Intravenous prophylactic antibiotic armActive comparator 1 intervention
Group C: Antimicrobial-coated suture armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Surgical site infection

Time frame
30 days post operative period

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Olawumi Olajide

Lead sponsor

Obafemi Awolowo University Teaching Hospital

Sponsor institution