Prevention of Surgical Site Infection in Open Paediatric Groin Surgeries Using Intravenous Prophylactic Antibiotics and Antimicrobial-coated Sutures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Antimicrobial-coated sutures, Intravenous Cefuroxime, Placebo intravenous injection.
- Who it may be relevant to
- Registry conditions: Inguinal Hernia, Hydroceles, Surgical Site Infection. Basic parameters: up to 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Nigeria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intravenous Prophylactic Antibiotics and Antimicrobial-Coated Sutures in Preventing Surgical Site Infection in Open Paediatric Groin Surgeries: A 3-arm Randomized Controlled Trial
Overview
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.
Interventions
- Device Antimicrobial-coated sutures
Use of Antimicrobial-coated sutures to close all layers of the surgical wound following open paediatric groin surgery - Drug Intravenous Cefuroxime
Intravenous cefuroxime is given at the induction of anaesthesia - Other Placebo intravenous injection
0.2ml of Vitamin Bco injection + 9.8ml sterile water
Primary outcome measures
- Surgical site infection [Time frame: 30 days post operative period]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Nigeria · 1 center
- Obafemi Awolowo University Teaching Hospitals Complex — Ile-Ife
Identifiers
NCT: NCT07346742 · ERC/2024/08/11