Surgical Site InfectionOPerAtiCNCT04366440
De-Implementation of Unnecessary Surgical Antibiotic Prophylaxis in Children
A study testing Order set review and modification with facilitation and Order set review and modification in people with Surgical Site Infection, run by Washington University School of Medicine at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 75 years
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Order set review and modification with facilitation and Order set review and modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,267 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Nov 2020to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
- General Surgery, Neurosurgery, Orthopedics, Otolaryngology, Plastic Surgery, Otolaryngology, and Urology
Who cannot join
- 1. Children undergoing clean or clean-contaminated procedures that are not collected by NSQIP-P data abstractors.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Michigan / CS Mott Children's Hospital
Ann Arbor, Michigan, 48109
Harvard Medical School / Boston Children's Hospital
Boston, Massachusetts, 02115
The Ohio State University College of Medicine / Nationwide Children's Hospital
Columbus, Ohio, 43205
Baylor College of Medicine / Texas Children's Hospital
Houston, Texas, 77030
University of Missouri - Kansas City / The Children's Mercy Hospital
Kansas City, Missouri, 64108
Vanderbilt University / Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
University of Utah / Primary Children's Hospital
Salt Lake City, Utah, 84108
University of Washington / Seattle Children's Hospital
Seattle, Washington, 98105
Washington University in St. Louis / St. Louis Children's Hospital
St Louis, Missouri, 63110
Johns Hopkins University School of Medicine / Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
About this study
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.
Read the detailed description
Antibiotics have revolutionized healthcare allowing clinicians the ability to treat life-threatening infections and to prevent infections following life-saving surgery. Unfortunately, antibiotic overuse results in antibiotic resistant bacteria and unnecessary adverse events including Clostridioides difficile infections (CDI). Data demonstrate that antibiotic resistant bacteria and CDI annually kill up to 150,000 and 29,000 Americans, respectively. Surgical antibiotic prophylaxis is a common area for unnecessary antibiotic use among children. Recent CDC surgical site infection (SSI) guidelines and the AAP Choosing Wisely Campaign recommend no postoperative antibiotic prophylaxis for procedures considered low risk for an SSI.
In this study, our team will develop and test two theoretically informed strategies to eliminate ("de-implement") unnecessary postoperative antibiotic prophylaxis through the collaboration of surgeons and antimicrobial stewardship programs (ASPs). One promising strategy is the implementation of standard surgical order sets, which offer relative ease of implementation and a systematic approach across surgical subspecialties. While evidence suggests that order set standardization is a good approach, barriers to implementation are commonly noted, especially the lack of engagement with clinicians affected by change when initiating a new strategy. As such, complementary strategies are needed to extend the impact of order set standardization.
This study will be guided by the i-PARIHS framework (Integrated Framework for Promoting Action on Research Implementation in Health Services), an implementation science framework designed to guide implementation of evidence-based practices. This framework posits that successful implementation of evidence into practice is a function of the quality and type of evidence to be implemented, the characteristics of the context where the evidence will be implemented, and the means by which it is integrated or facilitated into practice. Four primary constructs comprise the i-PARIHS framework: the innovation, recipients, context, and facilitation. Innovation describes the evidence and knowledge regarding a particular issue, as well as the qualities of the evidence that may influence how it is perceived by the potential user, recognizing that evidence may or may not be valuable to the end user based on local circumstances and priorities. Recipients are actors involved in implementation who may be affected by and influence the implementation of evidence. Context characterizes the circumstances in which knowledge and innovation uptake occurs, consisting of multiple factors at the micro, meso, and macro levels. Finally, integral to this framework is facilitation as the active mechanism by which uptake and implementation of evidence occurs, making it an ideal and appropriate fit for this study.
All research activities for this study will be conducted in 9 children's hospitals that participate in both the SHARPS Collaborative and NSQIP-P. Our participating hospitals are geographically dispersed and (like most children's hospitals) are located in urban settings. SHARPS Collaborative hospitals feature active ASPs operated by dedicated pharmacists and physician leaders. Clinicians (MD/DO or PharmD) overseeing ASPs and surgical champions in participating hospitals will implement the proposed strategies and collect implementation outcomes that quantify the extent to which the test strategies are successfully deployed in the hospital. The daily work of these individuals to improve antibiotic use includes frequent interaction with surgical specialties that perform clean and clean-contaminated surgeries. Implementing our proposed strategies via established ASP clinicians and a surgical leader (rather than, for example, directly by a member of the research team) will leverage existing relationships between these clinicians and their associated surgical teams, creating a more realistic circumstance under which new ASP strategies are implemented. This approach will provide better insight into the feasibility of implementing these strategies in a sustainable way in the future. In addition to being SHARPS Collaborative hospitals, our participating hospitals will also be NSQIP-P hospitals, each with a full-time, trained dedicated data abstractor collecting data on surgeries and surgical outcomes.
The investigators will compare the efficacy of the two strategies designed to reduce unnecessary postoperative antibiotic prophylaxis, using a cross-sectional stepped-wedge design. The investigators have identified 9 Children's Hospitals from across the US to participate in the study. Each of the 9 hospitals will be randomized into one of 3 clusters (cluster size = 3). All hospitals will begin with the control intervention-implementation of order set review and modification-at time 0. Each Step will last 6 months. Prior to the beginning of Step 1, Cluster 1 hospitals will receive the experimental intervention -order set review and modification plus facilitation. Just prior to steps 1, 2 and 3, the ASP teams will receive a 2-day in-person workshop led by the implementation scientist (Co-I Dr. McKay) and PI Dr. Newland, covering the specific facilitation strategies to be utilized. Every 6 months, an additional cluster will initiate the experimental condition (Steps 2 and 3). The amount of time each cluster will receive the experimental condition will be 30 months (Cluster 1), 24 months (Cluster 2), and 18 months (Cluster 3). Monthly study webinars will occur with all sites in step 0. During steps 1 and 2, sites in the experimental arm will have a monthly webinar separate from the group still in the control arm. By step 3 all sites will be a part of the same monthly webinar.
- Conditions
- Surgical Site Infection
- Being tested
- Order set review and modification with facilitation, Order set review and modification
- Keywords
- children, antimicrobial stewardship, post-operative antibiotic prophylaxis, Deimplementation
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Order set review and modification with facilitationBehavioural
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.
Order set review and modificationOther
The antimicrobial stewardship program will work to eliminate unnecessary post-operative antibiotics by reviewing and changing order sets of clean or clean-contaminated procedures.
| Study group | Role | What they receive |
|---|---|---|
| Order set review and modification | Other | The antimicrobial stewardship program will review and change order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics. Receives: Other: Order set review and modification |
| Order Set review and Modification plus facilitation | Other | 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. Receives: Behavioral: Order set review and modification with facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Clean and Clean-contaminated Cases in Children Receiving Post-operative Antibiotic Prophylaxis.
Clean and clean-contaminated surgical cases in children were assessed for whether they received post operative prophylaxis utilizing the Pediatric National Surgical Quality Improvement Project (NSQIP) database. A percentage was determined with the numerator being total number of clean and clean-contaminated cases receiving post operative surgical prophylaxis and the denominator is the total number of clean and clean-contaminated cases. The percentage of cases reflect the percentage of participants who received post operative surgical prophylaxis
Measured: 3 years
Secondary outcomes (2)
Rate of Surgical Site Infections (SSI) in Clean and Clean-contaminated Cases
Among the captured clean and clean-contaminated cases utilized in the primary outcome, the SSI rate per 100 cases was determined in patients both receiving and not receiving post-operative antibiotic prophylaxis.
Measured: 3 years
Rate of Clostridioides Difficile Infections (CDI) in Clean and Clean-contaminated Cases
Among the captured clean and clean-contaminated cases utilized in the primary outcome, the CDI rate per 100 cases was determined in patients both receiving and not receiving post-operative antibiotic prophylaxis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Nov 2020
- Primary completion1 Feb 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A stepped-wedge study design will be utilized. All sites will begin in the control intervention, order set review and modification. Sequentially, clusters of 3 hospitals will begin in the experimental intervention, order set review and modification plus facilitation.
- Masking
- None (open label)
- Enrolment
- 18,267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Jason G Newland, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366440
- Sponsor's protocol ID
- 201912100
- Other IDs
- 1R01HS026742-01A1
- Acronym
- OPerAtiC
- Status last verified
- Jun 2026
- First submitted
- 24 Apr 2020
- Last updated
- 9 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Logan LK, Renschler JP, Gandra S, Weinstein RA, Laxminarayan R; Centers for Disease Control; Prevention Epicenters Program. Carbapenem-Resistant Enterobacteriaceae in Children, United States, 1999-2012. Emerg Infect Dis. 2015 Nov;21(11):2014-21. doi: 10.3201/eid2111.150548.
PubMed 26486124Logan LK, Braykov NP, Weinstein RA, Laxminarayan R; CDC Epicenters Prevention Program. Extended-Spectrum beta-Lactamase-Producing and Third-Generation Cephalosporin-Resistant Enterobacteriaceae in Children: Trends in the United States, 1999-2011. J Pediatric Infect Dis Soc. 2014 Dec;3(4):320-8. doi: 10.1093/jpids/piu010. Epub 2014 Mar 19.
PubMed 26625452Logan LK, Gandra S, Mandal S, Klein EY, Levinson J, Weinstein RA, Laxminarayan R; Prevention Epicenters Program, US Centers for Disease Control and Prevention. Multidrug- and Carbapenem-Resistant Pseudomonas aeruginosa in Children, United States, 1999-2012. J Pediatric Infect Dis Soc. 2017 Nov 24;6(4):352-359. doi: 10.1093/jpids/piw064.
PubMed 27856730Herigon JC, Hersh AL, Gerber JS, Zaoutis TE, Newland JG. Antibiotic management of Staphylococcus aureus infections in US children's hospitals, 1999-2008. Pediatrics. 2010 Jun;125(6):e1294-300. doi: 10.1542/peds.2009-2867. Epub 2010 May 17.
PubMed 20478934Berrios-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP; Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017 Aug 1;152(8):784-791. doi: 10.1001/jamasurg.2017.0904.
PubMed 28467526Sandora TJ, Fung M, Melvin P, Graham DA, Rangel SJ. National Variability and Appropriateness of Surgical Antibiotic Prophylaxis in US Children's Hospitals. JAMA Pediatr. 2016 Jun 1;170(6):570-6. doi: 10.1001/jamapediatrics.2016.0019.
PubMed 27088649Harvey G, Kitson A. PARIHS revisited: from heuristic to integrated framework for the successful implementation of knowledge into practice. Implement Sci. 2016 Mar 10;11:33. doi: 10.1186/s13012-016-0398-2.
PubMed 27013464Kitson AL, Rycroft-Malone J, Harvey G, McCormack B, Seers K, Titchen A. Evaluating the successful implementation of evidence into practice using the PARiHS framework: theoretical and practical challenges. Implement Sci. 2008 Jan 7;3:1. doi: 10.1186/1748-5908-3-1.
PubMed 18179688Burnham JP, Olsen MA, Kollef MH. Re-estimating annual deaths due to multidrug-resistant organism infections. Infect Control Hosp Epidemiol. 2019 Jan;40(1):112-113. doi: 10.1017/ice.2018.304. Epub 2018 Nov 22. No abstract available.
PubMed 30463634Rycroft-Malone J, Seers K, Chandler J, Hawkes CA, Crichton N, Allen C, Bullock I, Strunin L. The role of evidence, context, and facilitation in an implementation trial: implications for the development of the PARIHS framework. Implement Sci. 2013 Mar 9;8:28. doi: 10.1186/1748-5908-8-28.
PubMed 23497438Helfrich CD, Damschroder LJ, Hagedorn HJ, Daggett GS, Sahay A, Ritchie M, Damush T, Guihan M, Ullrich PM, Stetler CB. A critical synthesis of literature on the promoting action on research implementation in health services (PARIHS) framework. Implement Sci. 2010 Oct 25;5:82. doi: 10.1186/1748-5908-5-82.
PubMed 20973988Liu J, Colditz GA. Optimal design of longitudinal data analysis using generalized estimating equation models. Biom J. 2017 Mar;59(2):315-330. doi: 10.1002/bimj.201600107. Epub 2016 Nov 23.
PubMed 27878852Liu J, Colditz GA. Relative efficiency of unequal versus equal cluster sizes in cluster randomized trials using generalized estimating equation models. Biom J. 2018 May;60(3):616-638. doi: 10.1002/bimj.201600262. Epub 2018 Mar 25.
PubMed 29577363McKay V, Malone S, Tetteh E, Saito J, Rangel S, Bono K, Tao J, Liu J, Obeng H, Atkinson A, Newland JG. Facilitation as an effective strategy to reduce excessive antibiotic prophylaxis in Children's hospitals: A stepped-wedge cluster randomized controlled trial. Implement Sci. 2025 Oct 21;20(1):45. doi: 10.1186/s13012-025-01455-2.
PubMed 41121325McKay V, Malone S, Tetteh E, Saito J, Rangel S, Bono K, Tao J, Liu J, Obeng H, Atkinson A, Newland J. Facilitation as an effective strategy to reduce excessive antibiotic prophylaxis in Children's hospitals: A stepped-wedge cluster randomized controlled trial. Res Sq [Preprint]. 2025 May 30:rs.3.rs-6579066. doi: 10.21203/rs.3.rs-6579066/v1.
PubMed 40502788
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-Implementation of Unnecessary Surgical Antibiotic Prophylaxis in Children
- ClinicalTrials.gov ID
- NCT04366440
- Acronym / sponsor ID
- OPerAtiC / 201912100
- Conditions
- Surgical Site Infection
- Keywords
- children, antimicrobial stewardship, post-operative antibiotic prophylaxis, Deimplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18,267 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Posted 9 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Antibiotics have revolutionized healthcare allowing clinicians the ability to treat life-threatening infections and to prevent infections following life-saving surgery. Unfortunately, antibiotic overuse results in antibiotic resistant bacteria and unnecessary adverse events including Clostridioides difficile infections (CDI). Data demonstrate that antibiotic resistant bacteria and CDI annually kill up to 150,000 and 29,000 Americans, respectively. Surgical antibiotic prophylaxis is a common area for unnecessary antibiotic use among children. Recent CDC surgical site infection (SSI) guidelines and the AAP Choosing Wisely Campaign recommend no postoperative antibiotic prophylaxis for procedures considered low risk for an SSI.
In this study, our team will develop and test two theoretically informed strategies to eliminate ("de-implement") unnecessary postoperative antibiotic prophylaxis through the collaboration of surgeons and antimicrobial stewardship programs (ASPs). One promising strategy is the implementation of standard surgical order sets, which offer relative ease of implementation and a systematic approach across surgical subspecialties. While evidence suggests that order set standardization is a good approach, barriers to implementation are commonly noted, especially the lack of engagement with clinicians affected by change when initiating a new strategy. As such, complementary strategies are needed to extend the impact of order set standardization.
This study will be guided by the i-PARIHS framework (Integrated Framework for Promoting Action on Research Implementation in Health Services), an implementation science framework designed to guide implementation of evidence-based practices. This framework posits that successful implementation of evidence into practice is a function of the quality and type of evidence to be implemented, the characteristics of the context where the evidence will be implemented, and the means by which it is integrated or facilitated into practice. Four primary constructs comprise the i-PARIHS framework: the innovation, recipients, context, and facilitation. Innovation describes the evidence and knowledge regarding a particular issue, as well as the qualities of the evidence that may influence how it is perceived by the potential user, recognizing that evidence may or may not be valuable to the end user based on local circumstances and priorities. Recipients are actors involved in implementation who may be affected by and influence the implementation of evidence. Context characterizes the circumstances in which knowledge and innovation uptake occurs, consisting of multiple factors at the micro, meso, and macro levels. Finally, integral to this framework is facilitation as the active mechanism by which uptake and implementation of evidence occurs, making it an ideal and appropriate fit for this study.
All research activities for this study will be conducted in 9 children's hospitals that participate in both the SHARPS Collaborative and NSQIP-P. Our participating hospitals are geographically dispersed and (like most children's hospitals) are located in urban settings. SHARPS Collaborative hospitals feature active ASPs operated by dedicated pharmacists and physician leaders. Clinicians (MD/DO or PharmD) overseeing ASPs and surgical champions in participating hospitals will implement the proposed strategies and collect implementation outcomes that quantify the extent to which the test strategies are successfully deployed in the hospital. The daily work of these individuals to improve antibiotic use includes frequent interaction with surgical specialties that perform clean and clean-contaminated surgeries. Implementing our proposed strategies via established ASP clinicians and a surgical leader (rather than, for example, directly by a member of the research team) will leverage existing relationships between these clinicians and their associated surgical teams, creating a more realistic circumstance under which new ASP strategies are implemented. This approach will provide better insight into the feasibility of implementing these strategies in a sustainable way in the future. In addition to being SHARPS Collaborative hospitals, our participating hospitals will also be NSQIP-P hospitals, each with a full-time, trained dedicated data abstractor collecting data on surgeries and surgical outcomes.
The investigators will compare the efficacy of the two strategies designed to reduce unnecessary postoperative antibiotic prophylaxis, using a cross-sectional stepped-wedge design. The investigators have identified 9 Children's Hospitals from across the US to participate in the study. Each of the 9 hospitals will be randomized into one of 3 clusters (cluster size = 3). All hospitals will begin with the control intervention-implementation of order set review and modification-at time 0. Each Step will last 6 months. Prior to the beginning of Step 1, Cluster 1 hospitals will receive the experimental intervention -order set review and modification plus facilitation. Just prior to steps 1, 2 and 3, the ASP teams will receive a 2-day in-person workshop led by the implementation scientist (Co-I Dr. McKay) and PI Dr. Newland, covering the specific facilitation strategies to be utilized. Every 6 months, an additional cluster will initiate the experimental condition (Steps 2 and 3). The amount of time each cluster will receive the experimental condition will be 30 months (Cluster 1), 24 months (Cluster 2), and 18 months (Cluster 3). Monthly study webinars will occur with all sites in step 0. During steps 1 and 2, sites in the experimental arm will have a monthly webinar separate from the group still in the control arm. By step 3 all sites will be a part of the same monthly webinar.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A stepped-wedge study design will be utilized. All sites will begin in the control intervention, order set review and modification. Sequentially, clusters of 3 hospitals will begin in the experimental intervention, order set review and modification plus facilitation.
| Arm | Type | Receives |
|---|---|---|
| Order set review and modification | Other | Other: Order set review and modificationThe antimicrobial stewardship program will review and change order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics. |
| Order Set review and Modification plus facilitation | Other | Behavioral: Order set review and modification with facilitationThe 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. |
Who may qualify
- Ages
- 0 days to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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:
- General Surgery, Neurosurgery, Orthopedics, Otolaryngology, Plastic Surgery, Otolaryngology, and Urology
Key exclusion criteria (1 listed)
- 1. Children undergoing clean or clean-contaminated procedures that are not collected by NSQIP-P data abstractors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Order set review and modification with facilitationThe 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. | Behavioural | Order Set review and Modification plus facilitation |
| Order set review and modificationThe antimicrobial stewardship program will work to eliminate unnecessary post-operative antibiotics by reviewing and changing order sets of clean or clean-contaminated procedures. | Other | Order set review and modification |
Primary outcome
Percentage of Clean and Clean-contaminated Cases in Children Receiving Post-operative Antibiotic Prophylaxis.
Time frame: 3 years
Clean and clean-contaminated surgical cases in children were assessed for whether they received post operative prophylaxis utilizing the Pediatric National Surgical Quality Improvement Project (NSQIP) database. A percentage was determined with the numerator being total number of clean and clean-contaminated cases receiving post operative surgical prophylaxis and the denominator is the total number of clean and clean-contaminated cases. The percentage of cases reflect the percentage of participants who received post operative surgical prophylaxis
2 secondary outcomes
Rate of Surgical Site Infections (SSI) in Clean and Clean-contaminated Cases
Time frame: 3 years
Rate of Clostridioides Difficile Infections (CDI) in Clean and Clean-contaminated Cases
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26486124Logan LK, Renschler JP, Gandra S, Weinstein RA, Laxminarayan R; Centers for Disease Control; Prevention Epicenters Program. Carbapenem-Resistant Enterobacteriaceae in Children, United States, 1999-2012. Emerg Infect Dis. 2015 Nov;21(11):2014-21. doi: 10.3201/eid2111.150548.
- Background: PubMed 26625452Logan LK, Braykov NP, Weinstein RA, Laxminarayan R; CDC Epicenters Prevention Program. Extended-Spectrum beta-Lactamase-Producing and Third-Generation Cephalosporin-Resistant Enterobacteriaceae in Children: Trends in the United States, 1999-2011. J Pediatric Infect Dis Soc. 2014 Dec;3(4):320-8. doi: 10.1093/jpids/piu010. Epub 2014 Mar 19.
- Background: PubMed 27856730Logan LK, Gandra S, Mandal S, Klein EY, Levinson J, Weinstein RA, Laxminarayan R; Prevention Epicenters Program, US Centers for Disease Control and Prevention. Multidrug- and Carbapenem-Resistant Pseudomonas aeruginosa in Children, United States, 1999-2012. J Pediatric Infect Dis Soc. 2017 Nov 24;6(4):352-359. doi: 10.1093/jpids/piw064.
- Background: PubMed 20478934Herigon JC, Hersh AL, Gerber JS, Zaoutis TE, Newland JG. Antibiotic management of Staphylococcus aureus infections in US children's hospitals, 1999-2008. Pediatrics. 2010 Jun;125(6):e1294-300. doi: 10.1542/peds.2009-2867. Epub 2010 May 17.
- Background: PubMed 28467526Berrios-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP; Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017 Aug 1;152(8):784-791. doi: 10.1001/jamasurg.2017.0904.
- Background: PubMed 27088649Sandora TJ, Fung M, Melvin P, Graham DA, Rangel SJ. National Variability and Appropriateness of Surgical Antibiotic Prophylaxis in US Children's Hospitals. JAMA Pediatr. 2016 Jun 1;170(6):570-6. doi: 10.1001/jamapediatrics.2016.0019.
- Background: PubMed 27013464Harvey G, Kitson A. PARIHS revisited: from heuristic to integrated framework for the successful implementation of knowledge into practice. Implement Sci. 2016 Mar 10;11:33. doi: 10.1186/s13012-016-0398-2.
- Background: PubMed 18179688Kitson AL, Rycroft-Malone J, Harvey G, McCormack B, Seers K, Titchen A. Evaluating the successful implementation of evidence into practice using the PARiHS framework: theoretical and practical challenges. Implement Sci. 2008 Jan 7;3:1. doi: 10.1186/1748-5908-3-1.
- Background: PubMed 30463634Burnham JP, Olsen MA, Kollef MH. Re-estimating annual deaths due to multidrug-resistant organism infections. Infect Control Hosp Epidemiol. 2019 Jan;40(1):112-113. doi: 10.1017/ice.2018.304. Epub 2018 Nov 22. No abstract available.
- Background: PubMed 23497438Rycroft-Malone J, Seers K, Chandler J, Hawkes CA, Crichton N, Allen C, Bullock I, Strunin L. The role of evidence, context, and facilitation in an implementation trial: implications for the development of the PARIHS framework. Implement Sci. 2013 Mar 9;8:28. doi: 10.1186/1748-5908-8-28.
- Background: PubMed 20973988Helfrich CD, Damschroder LJ, Hagedorn HJ, Daggett GS, Sahay A, Ritchie M, Damush T, Guihan M, Ullrich PM, Stetler CB. A critical synthesis of literature on the promoting action on research implementation in health services (PARIHS) framework. Implement Sci. 2010 Oct 25;5:82. doi: 10.1186/1748-5908-5-82.
- Background: PubMed 27878852Liu J, Colditz GA. Optimal design of longitudinal data analysis using generalized estimating equation models. Biom J. 2017 Mar;59(2):315-330. doi: 10.1002/bimj.201600107. Epub 2016 Nov 23.
- SHARPS Collaborative WebsiteLink provided by the sponsor.
- NSQIP-P WebsiteLink provided by the sponsor.
- CDC Threat Report 2019Link provided by the sponsor.
- American Academy of Pediatrics Choosing Wisely- Infectious DiseasesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Abdominal Aortic Aneurysm, Morbid Obesity
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A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason G Newland, MD principal investigator
Washington University School of Medicine
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Order set review and modification with facilitation and Order set review and modification in people with Surgical Site Infection, run by Washington University School of Medicine at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Clean and Clean-contaminated Cases in Children Receiving Post-operative Antibiotic Prophylaxis. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04366440, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.