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NCT Number: NCT07346742

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

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.

Recruiting

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Hydroceles Infections Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Site Infection Surgical Wound Infection Wound Infection

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Obafemi Awolowo University Teaching Hospitals Complex

Ile-Ife, Osun State, 220282, Nigeria

Location status: Recruiting

Location contact

Olawumi Olajide, M.B.Ch.B

CONTACT

[email protected]

+2348038696179

Olawumi Olajide, M.B.Ch.B

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with clinical conditions requiring daycase open groin surgery

Exclusion criteria

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

Treatment and study plan

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

0.2ml of Vitamin Bco injection + 9.8ml sterile water

Primary outcomes

  1. Surgical site infection

    Time frame: 30 days post operative period

Study contacts

Contact information is provided by the study sponsor or research team.

Olawumi Olajide, M.B.Ch.B

CONTACT

[email protected]

+2348038696179

Sponsors and collaborators

Lead sponsor

Olawumi Olajide

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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