Intravenous Prophylactic Antibiotics and Antimicrobial-Coated Sutures in Preventing Surgical Site Infection in Open Paediatric Groin Surgeries: A 3-arm Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Olawumi Olajide
- Enrollment
- 174
- Locations
- 1
- Primary Endpoint
- Surgical site infection
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
No Antibiotics arm
Participants will have intravenous placebo injection given at the induction of anaesthesia and their surgical wounds closed using non-coated sutures
Intervention: Placebo intravenous injection (Other)
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
Intervention: Intravenous Cefuroxime (Drug)
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
Intervention: Antimicrobial-coated sutures (Device)
Outcomes
Primary Outcomes
Surgical site infection
Time Frame: 30 days post operative period
Secondary Outcomes
No secondary outcomes reported
Investigators
Olawumi Olajide
Senior Registrar
Obafemi Awolowo University Teaching Hospital