Preventing Surgical Site Infection in Paediatric Groin Surgeries: Intravenous Prophylactic Antibiotics and Antimicrobial-Coated Sutures
This study aims to prevent surgical site infections in children undergoing groin surgeries by using intravenous prophylactic antibiotics and antimicrobial-coated sutures.
Antimicrobial-coated sutures
+ Intravenous Cefuroxime
+ Placebo intravenous injection
Hernia+7
+ Hernia, Inguinal
+ Infections
Prevention Study
Summary
Study start date: March 9, 2025
Actual date on which the first participant was enrolled.This clinical trial aims to find out if using intravenous prophylactic antibiotics and antimicrobial-coated sutures can help prevent surgical site infections in children who are having open groin surgeries. The study is important because it could help improve care and reduce the risk of infections for children undergoing these types of surgeries. The trial will compare the rate of surgical site infections in surgeries without antibiotics, with the use of intravenous prophylactic antibiotics, and with the use of antimicrobial-coated sutures. Participants in this study will be randomly assigned to one of three groups on the morning of their surgery. Those in group A will receive an intravenous placebo injection at the start of anesthesia and their surgical wounds will be closed using non-coated sutures. Participants in group B will receive an intravenous prophylactic antibiotic at the start of anesthesia and their surgical wounds will also be closed using non-coated sutures. Those in group C will receive an intravenous placebo injection at the start of anesthesia and their surgical wounds will be closed using antimicrobial-coated sutures. All participants will visit the clinic on postoperative days 5, 13, and 30 for a review of their surgical wounds to check for any signs of infection following the CDC guidelines.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.174 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 15 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * All patients with clinical conditions requiring daycase open groin surgery Exclusion Criteria: 1. Re-operations 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorGroup III
PlaceboStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Obafemi Awolowo University Teaching Hospitals Complex
Ile-Ife, NigeriaOpen Obafemi Awolowo University Teaching Hospitals Complex in Google Maps