Evidence map›Paper›PMID 36096826›Full record

Trial reportTrials2022

A pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solutions in open fractures (Aqueous-PREP): statistical analysis plan.

Nathan N O'Hara, Diane Heels-Ansdell, Sofia Bzovsky, Shannon Dodds, Lehana Thabane, Mohit Bhandari, Gordon Guyatt, P J Devereaux, Gerard P Slobogean, Sheila Sprague and 1 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03385304 (Aqueous-PREP), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.2field-weighted citation impact, top 45% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03385304 phase4completednot on this map

Aqueous-PREP: A Pragmatic Randomized Trial Evaluating Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures

TypeinterventionalSponsorUniversity of Maryland, BaltimoreRan2018 to 2022Enrolled1,638ConditionsSurgical Site Infection, Unplanned Fracture-Related Reoperation, Open Appendicular FractureArms10% povidone-iodine (1% free iodine) in purified water, 4% chlorhexidine gluconate (CHG) in purified water
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 2 countries.

Nathan N O'HaraR Adams Cowley Shock Trauma Center, Department of Orthopaedics, University of Maryland School of Medicine, 22 South Greene Street, Baltimore, MD, USA.
Diane Heels-AnsdellDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Sofia BzovskyDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Shannon DoddsDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Lehana ThabaneDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Mohit BhandariDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Gordon GuyattDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
P J DevereauxDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Gerard P SlobogeanR Adams Cowley Shock Trauma Center, Department of Orthopaedics, University of Maryland School of Medicine, 22 South Greene Street, Baltimore, MD, USA.
Sheila SpragueDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada. sprags@mcmaster.ca.ORCID http://orcid.org/0000-0003-1466-8063
PREP-IT Investigators
Impact · CAMcMaster University · CAUniversity of Maryland, Baltimore · USPopulation Health Research Institute · CA

Funding

U.S. Department of Defense W81XWH-17-1-070
6 · The paper itself

Abstract

backgroundApproximately 1 in 10 patients with a surgically treated open fracture will develop a surgical site infection. The Aqueous-PREP trial will investigate the effect of 10% povidone-iodine versus 4% chlorhexidine in aqueous antiseptic solutions in reducing infections after open fracture surgery. The study protocol was published in April 2020. METHODS AND

designThe Aqueous-PREP trial is a pragmatic, multicenter, open-label, randomized multiple period cluster crossover trial. Each participating cluster is randomly assigned in a 1:1 ratio to provide 1 of the 2 study interventions on all eligible patients during a study period. The intervention periods are 2 months in length. After completing a 2-month period, the participating cluster crosses over to the alternative intervention. We plan to enroll a minimum of 1540 patients at 14 sites.

resultsThe primary outcome is surgical site infection guided by the Centers for Disease Control and Prevention's National Healthcare Safety Network reporting criteria (2017). All participants' surgical site infection surveillance period will end 30 days after definitive fracture management surgery for superficial infections and 90 days after definitive fracture management surgery for deep incisional or organ/space infections [1]. The secondary outcome is an unplanned fracture-related reoperation within 12 months of the fracture.

conclusionThis manuscript serves as the formal statistical analysis plan (version 1.0) for the Aqueous-PREP trial. The statistical analysis plan was completed on February 28, 2022.

Indexed as

Anti-Infective Agents, LocalFractures, OpenChlorhexidineHumansPovidone-IodineSurgical Wound InfectionUnited StatesWaterAnti-Infective Agents, LocalChlorhexidinePovidone-IodineWaterAqueous antiseptic solutionsOpen fractureSurgical site infection

Identifiers

PMID36096826
PMCPMC9465853
OpenAlexW4295242113

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.