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Guideline Adherence Intervention for Preventing Surgical Site Infections in Children (OPerAtiC Trial)

N/A

Waitlist Available

Led By Jason G Newland, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 specialties included in NSQIP-P: General Surgery, Neurosurgery, Orthopedics, Otolaryngology, Plastic Surgery, Otolaryngology, and Urology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

OPerAtiC Trial Summary

This trial is testing whether adding a staff member to help surgeons follow antibiotic guidelines will reduce the number of unnecessary antibiotics given to children after low-risk surgery.

Who is the study for?

This trial is for children undergoing low-risk surgeries at certain Children's Hospitals that are tracked by NSQIP-P. It includes general, neurosurgery, orthopedics, otolaryngology (ENT), plastic surgery, and urology procedures. Kids not part of the NSQIP-P data collection or having other types of surgeries are excluded.Check my eligibility

What is being tested?

The study aims to find the best way to stop giving unnecessary antibiotics after surgery in kids. It compares two methods: just reviewing surgical orders versus reviewing orders plus extra guidance from an Antibiotic Stewardship Program (ASP).See study design

What are the potential side effects?

Since this trial focuses on reducing antibiotic use rather than administering drugs, it doesn't directly test side effects like medication trials do. However, there may be risks related to changes in postoperative care.

OPerAtiC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My surgery was at a Children's Hospital in the study and tracked by NSQIP-P.

Select...

I had a surgery that was considered clean or slightly contaminated in one of the listed specialties.

OPerAtiC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of clean and clean-contaminated cases in children receiving post-operative antibiotic prophylaxis.

Secondary outcome measures

Rate of Clostridioides difficile infections (CDI) in clean and clean-contaminated cases

Rate of Surgical Site Infections (SSI) in clean and clean-contaminated cases

Other outcome measures

Implementation Outcome: Acceptability of the Interventions

Implementation Outcome: Appropriateness of the Interventions

Implementation Outcome: Feasibility of the Interventions

OPerAtiC Trial Design

2Treatment groups

Experimental Treatment

Group I: Order set review and modificationExperimental Treatment1 Intervention

The antimicrobial stewardship program will review and change order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.

Group II: Order Set review and Modification plus facilitationExperimental Treatment1 Intervention

The antimicrobial stewardship program will receive facilitation training to aid in reviewing and changing order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,295,709 Total Patients Enrolled

Agency for Healthcare Research and Quality (AHRQ)FED

399 Previous Clinical Trials

6,818,348 Total Patients Enrolled

Jason G Newland, MDPrincipal InvestigatorWashington University School of Medicine

Media Library

Order Set review and Modification plus facilitation Clinical Trial Eligibility Overview. Trial Name: NCT04366440 — N/A

Surgical Site Infection Research Study Groups: Order Set review and Modification plus facilitation, Order set review and modification

Surgical Site Infection Clinical Trial 2023: Order Set review and Modification plus facilitation Highlights & Side Effects. Trial Name: NCT04366440 — N/A

Order Set review and Modification plus facilitation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04366440 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to join this research endeavor?

"To be included in this experiment, participants must have an infectious disease and a maximum age of 75. This study targetting for 4,000 people to join its ranks."

Answered by AI

Are there numerous healthcare facilities administering this research in Canada?

"The medical trial is accepting patients at 10 different sites, such as the University of Utah / Primary Children's Hospital in Salt Lake City and Vanderbilt University / Monroe Carell Jr. Children's Hospital at Vanderbilt located in Nashville, along with 8 other locations."

Answered by AI

Does the study enrollment criteria allow those over 40 to participate?

"The age range that this trial is recruiting for goes from 0 days to 75 years."

Answered by AI

Are there any vacancies available for participants of this clinical trial?

"Unfortunately, the clinicaltrials.gov database indicates that this trial is now closed to new participants as of May 19th 2022 - despite beginning recruitment on November 1st 2020. However, there are 71 other medical studies actively seeking enrolment right now."

Answered by AI

Recent research and studies

Biometrical JournalJournal

Relative Efficiency of Unequal Versus Equal Cluster Sizes in Cluster Randomized Trials Using Generalized Estimating Equation Models

Liu, Jingxia, and Graham A. Colditz. 2018. “Relative Efficiency of Unequal Versus Equal Cluster Sizes in Cluster Randomized Trials Using Generalized Estimating Equation Models”. Biometrical Journal. Wiley. doi:10.1002/bimj.201600262.

Implementation ScienceJournal

Evaluating the Successful Implementation of Evidence into Practice Using the Parihs Framework: Theoretical and Practical Challenges

Kitson, Alison L, Jo Rycroft-Malone, Gill Harvey, Brendan McCormack, Kate Seers, and Angie Titchen. 2008. “Evaluating the Successful Implementation of Evidence into Practice Using the Parihs Framework: Theoretical and Practical Challenges”. Implementation Science. Springer Science and Business Media LLC. doi:10.1186/1748-5908-3-1.

JAMA PediatricsJournal

National Variability and Appropriateness of Surgical Antibiotic Prophylaxis in US Children’s Hospitals

Sandora, Thomas J., Monica Fung, Patrice Melvin, Dionne A. Graham, and Shawn J. Rangel. 2016. “National Variability and Appropriateness of Surgical Antibiotic Prophylaxis in US Children’s Hospitals”. JAMA Pediatrics. American Medical Association (AMA). doi:10.1001/jamapediatrics.2016.0019.

Journal of the Pediatric Infectious Diseases SocietyJournal