De-Implementation of Unnecessary Surgical Antibiotic Prophylaxis in Children (NCT04366440) | Clinical Trial Compass
CompletedNot Applicable
De-Implementation of Unnecessary Surgical Antibiotic Prophylaxis in Children
United States18,267 participantsStarted 2020-11-01
Plain-language summary
The overall objective of this study is to identify the best strategy to eliminate unnecessary antibiotic use after surgery in pediatric surgical procedures considered low-risk for an SSI. Based on literature and our preliminary data suggesting surgeons will not fully accept standardized order sets based on current guidelines, the investigators hypothesize that order set modification combined with ASP facilitation will outperform standard order set modification alone in de-implementing unnecessary postoperative antibiotic use.
Who can participate
Age range
0 Days – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Surgeries performed at the Children's Hospitals included in the study and are collected by NSQIP-P.
. Clean and clean-contaminated surgical procedures within the following specialties that are included in NSQIP-P:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at reducing or stopping post-operative antibiotics in children after clean or clean-contaminated surgeries — if my child is having one of those types of procedures, can you help me understand whether routine post-operative antibiotics are actually considered necessary in their specific case?
2Since this trial has already been completed, have its findings changed the way your practice or hospital handles antibiotic use after pediatric surgery, and would those updated guidelines apply to my child's care?
3The study focused on 'de-implementing' unnecessary antibiotic use — what are the real risks of surgical site infection for my child's particular procedure if post-operative antibiotics are reduced or skipped?
4Are there specific characteristics about my child — like their age, immune status, or the complexity of their surgery — that would make them more or less likely to need post-operative antibiotics regardless of what this trial found?
5If the results of this trial support giving fewer post-operative antibiotics in children, how would you weigh that evidence against any individual factors that might make my child's situation different from the kids studied in the trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Clean and Clean-contaminated Cases in Children Receiving Post-operative Antibiotic Prophylaxis.