Prevention of Surgical Site Infection in Open Paediatric Groin Surgeries Using Intravenous Prophylactic Antibiotics and Antimicrobial-coated Sutures
NCT ID: NCT07346742
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
174 participants
INTERVENTIONAL
2025-03-09
2026-02-27
Brief Summary
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• 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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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No Antibiotics arm
Participants will have intravenous placebo injection given at the induction of anaesthesia and their surgical wounds closed using non-coated sutures
Placebo intravenous injection
0.2ml of Vitamin Bco injection + 9.8ml sterile water
Intravenous prophylactic antibiotic arm
Participants will have an intravenous prophylactic antibiotics given at the induction of anaesthesia and their wounds closed with non-coated sutures
Intravenous Cefuroxime
Intravenous cefuroxime is given at the induction of anaesthesia
Antimicrobial-coated suture arm
Participants will have an intravenous placebo injection given at the induction of anaesthesia and their wounds closed with antimicrobial-coated sutures
Antimicrobial-coated sutures
Use of Antimicrobial-coated sutures to close all layers of the surgical wound following open paediatric groin surgery
Interventions
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Antimicrobial-coated sutures
Use of Antimicrobial-coated sutures to close all layers of the surgical wound following open paediatric groin surgery
Intravenous Cefuroxime
Intravenous cefuroxime is given at the induction of anaesthesia
Placebo intravenous injection
0.2ml of Vitamin Bco injection + 9.8ml sterile water
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
15 Years
ALL
No
Sponsors
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Olawumi Olajide
OTHER
Responsible Party
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Olawumi Olajide
Senior Registrar
Locations
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Obafemi Awolowo University Teaching Hospitals Complex
Ile-Ife, Osun State, Nigeria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ERC/2024/08/11
Identifier Type: -
Identifier Source: org_study_id
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