Evidence map›Paper›PMID 33648577›Full record

ArticlePilot and feasibility studies2021

Pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solution in open fractures (Aqueous-PREP): the feasibility of a cluster randomized crossover study.

Sheila Sprague, Paige Guyatt, Sofia Bzovsky, Uyen Nguyen, Mohit Bhandari, Lehana Thabane, Brad Petrisor, Herman S Johal, Jordan Leonard, Shannon Dodds and 8 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2021. 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. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 39% 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

1 citing paper in PubMed, 6 citations in OpenAlex.

  1. Article
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

18 authors at 3 institutions in 2 countries.

Sheila SpragueDivision of Orthopedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada. sprags@mcmaster.ca.ORCID http://orcid.org/0000-0003-1466-8063
Paige GuyattDivision of Orthopedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Sofia BzovskyDivision of Orthopedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Uyen NguyenDivision of Orthopedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Mohit BhandariDivision of Orthopedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Lehana ThabaneDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Brad PetrisorDivision of Orthopedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Herman S JohalDivision of Orthopedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Jordan LeonardDivision of Orthopedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Shannon DoddsDivision of Orthopedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Franca MossutoDivision of Orthopedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Robert V O'TooleR Adams Cowley Shock Trauma Center, Department of Orthopedics, University of Maryland School of Medicine, Baltimore, MD, USA.
Andrea HoweR Adams Cowley Shock Trauma Center, Department of Orthopedics, University of Maryland School of Medicine, Baltimore, MD, USA.
Haley K DemyanovichR Adams Cowley Shock Trauma Center, Department of Orthopedics, University of Maryland School of Medicine, Baltimore, MD, USA.
Megan CamaraR Adams Cowley Shock Trauma Center, Department of Orthopedics, University of Maryland School of Medicine, Baltimore, MD, USA.
Nathan N O'HaraR Adams Cowley Shock Trauma Center, Department of Orthopedics, University of Maryland School of Medicine, Baltimore, MD, USA.
Gerard P SlobogeanR Adams Cowley Shock Trauma Center, Department of Orthopedics, University of Maryland School of Medicine, Baltimore, MD, USA.
PREP-IT Investigators
McMaster University · CAUniversity of Maryland, Baltimore · USImpact · CA

Funding

U.S. Department of Defense W81XWH-17-1-010
6 · The paper itself

Abstract

backgroundPreoperative antiseptic skin solutions are used prior to most surgical procedures; however, there is no definitive research comparing infection-related outcomes following use of the various solutions available to orthopedic trauma surgeons. The objective of this pilot study was to test the feasibility of a cluster randomized crossover trial that assesses the comparative effectiveness of a 10% povidone-iodine solution versus a 4% chlorhexidine gluconate solution for the management of open fractures.

methodsTwo orthopedic trauma centers participated in this pilot study. Each of these clinical sites was randomized to a starting solution (povidone-iodine solution or chlorhexidine gluconate) then subsequently crossed over to the other treatment after 2 months. During the 4-month enrollment phase, we assessed compliance, enrollment rates, participant follow-up, and accurate documentation of the primary clinical outcome. Feasibility outcomes included (1) the implementation of the interventions during a run-in period; (2) enrollment of participants during two 2-month enrollment phases; (3) application of the trial interventions as per the cluster randomization crossover scheme; (4) participant follow-up; and (5) accurate documentation of the primary outcome (surgical site infection). Feasibility outcomes were summarized using descriptive statistics reported as means (standard deviation) or medians (first quartile, third quartile) for continuous variables depending on their distribution and counts (percentage) for categorical variables. Corresponding 95% confidence intervals (CIs) were also reported.

resultsAll five of the criteria for feasibility were met. During the run-in phase, all 18 of the eligible patients identified at the two clinical sites received the correct cluster-assigned treatment. A total of 135 patients were enrolled across both sites during the 4-month recruitment phase, which equates to 92% (95% CI 85.9 to 96.4%) of eligible patients being enrolled. Compliance with the assigned treatment in the pilot study was 98% (95% CI 93.5 to 99.8%). Ninety-eight percent (95% CI 93.5 to 99.8%) of participants completed the 90-day post-surgery follow-up and the primary outcome (SSI) was accurately documented for 100% (95% CI 96.6 to 100.0%) of the participants.

conclusionsThese results confirm the feasibility of a definitive study comparing antiseptic solutions using a cluster randomized crossover trial design. Building upon the infrastructure established during the pilot phase, a definitive study has been successfully initiated.

trial registrationClincialTrials.gov , number NCT03385304 . Registered December 28, 2017.

Indexed as

Aqueous antiseptic skin solutionCluster crossoverFeasibilityOpen fracturesPilot studySurgical site infection

Identifiers

PMID33648577
PMCPMC7919062
OpenAlexW3134398616

What OpenQuestion holds

Textmetadata
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.