@article{d1dc6d9e0d974e00862b83b95b2f48c5,
title = "Pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solution in open fractures (Aqueous-PREP): the feasibility of a cluster randomized crossover study",
abstract = "Background: Preoperative 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. Methods: Two 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. Results: All 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. Conclusions: These 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 registration: ClincialTrials.gov, number NCT03385304. Registered December 28, 2017.",
keywords = "Aqueous antiseptic skin solution, Cluster crossover, Feasibility, Open fractures, Pilot study, Surgical site infection",
author = "{The PREP-IT Investigators} and Sheila Sprague and Paige Guyatt and Sofia Bzovsky and Uyen Nguyen and Mohit Bhandari and Lehana Thabane and Brad Petrisor and Johal, {Herman S.} and Jordan Leonard and Shannon Dodds and Franca Mossuto and O{\textquoteright}Toole, {Robert V.} and Andrea Howe and Demyanovich, {Haley K.} and Megan Camara and O{\textquoteright}Hara, {Nathan N.} and Slobogean, {Gerard P.} and Jeffrey Wells and D{\textquoteright}Alleyrand, {Jean Claude} and Harris, {Anthony D.} and Mullins, {Daniel C.} and Amber Wood and {Della Rocca}, {Gregory J.} and Joan Hebden and Lucas Marchand and O{\textquoteright}Hara, {Lyndsay M.} and Robert Zura and Gardner, {Michael J.} and Jenna Blasman and Jonah Davies and Stephen Liang and Monica Taljaard and Devereaux, {P. J.} and Guyatt, {Gordon H.} and Diane Heels-Ansdell and Debra Marvel and Jana Palmer and Jeff Friedrich and Grissom, {Ms Frances} and Gitajn, {I. Leah} and Jeray, {Kyle J.} and Saam Morshed and Petrisor, {Bradley A.} and Joshi, {Manjari G.} and Justin Fowler and Jessica Rivera and Max Talbot and Alisha Garibaldi and Silvia Li and David Pogorzelski and Alejandra Rojas and Taryn Scott and {Del Fabbro}, Gina and Szasz, {Olivia Paige} and Paula McKay and Joshua Rudnicki and Haley Demyanovich and Kelly Little and Mullins, {C. Daniel} and Michelle Medeiros and Eric Kettering and Diamond Hale and Andrew Eglseder and Aaron Johnson and Christopher Langhammer and Christopher Lebrun and Theodore Manson and Jason Nascone and Ebrahim Paryavi and Raymond Pensy and Andrew Pollak and Marcus Sciadini and Yasmin Degani and Katherine Joseph and Petrisor, {Brad A.} and Herman Johal and Bill Ristevski and Dale Williams and Matthew Denkers and Krishan Rajaratnam and Jamal Al-Asiri and Marcano-Fern{\'a}ndez, {Francesc A.} and Jodi Gallant and Federico Persico and Marko Gjorgjievski and Annie George and Natoli, {Roman M.} and Gaski, {Greg E.} and McKinley, {Todd O.} and Virkus, {Walter W.} and Sorkin, {Anthony T.} and Szatkowski, {Jan P.} and Baele, {Joseph R.} and Mullis, {Brian H.} and Hill, {Lauren C.} and Andrea Hudgins and Patrick Osborn and Sarah Pierrie and Eric Martinez and Joseph Kimmel and Adams, {John D.} and Beckish, {Michael L.} and Bray, {Christopher C.} and Brown, {Timothy R.} and Cross, {Andrew W.} and Timothy Dew and Faucher, {Gregory K.} and Gurich, {Richard W.} and Lazarus, {David E.} and Millon, {S. John} and Palmer, {M. Jason} and Porter, {Scott E.} and Schaller, {Thomas M.} and Sridhar, {Michael S.} and Sanders, {John L.} and {Edwin Rudisill}, L. and Garitty, {Michael J.} and Poole, {Andrew S.} and Sims, {Michael L.} and Walker, {Clark M.} and Carlisle, {Robert M.} and Hofer, {Erin Adams} and Huggins, {Brandon S.} and Hunter, {Michael D.} and Marshall, {William A.} and Ray, {Shea Bielby} and Smith, {Cory D.} and Altman, {Kyle M.} and Bedard, {Julia C.} and Loeffler, {Markus F.} and Pichiotino, {Erin R.} and Cole, {Austin A.} and Maltz, {Ethan J.} and Wesley Parker and Ramsey, {T. Bennett} and Alex Burnikel and Michael Colello and Russell Stewart and Jeremy Wise and Moody, {M. Christian} and Tanner, {Stephanie L.} and Snider, {Rebecca G.} and Townsend, {Christine E.} and Pham, {Kayla H.} and Abigail Martin and Emily Robertson and Theodore Miclau and Utku Kandemir and Meir Marmor and Amir Matityahu and McClellan, {R. Trigg} and Eric Meinberg and David Shearer and Paul Toogood and Anthony Ding and Erin Donohue and Tigist Belaye and Eleni Berhaneselase and Alexandra Paul and Kartik Garg and Gary, {Joshua L.} and Warner, {Stephen J.} and Munz, {John W.} and Choo, {Andrew M.} and Achor, {Timothy S.} and Routt, {Milton L.} and Mayank Rao and Guillermo Pechero and Adam Miller and Hagen, {Jennifer E.} and Matthew Patrick and Richard Vlasak and Thomas Krupko and Kalia Sadasivan and Chris Koenig and Daniel Bailey and Daniel Wentworth and Chi Van and Justin Schwartz and Niloofar Dehghan and Jones, {Clifford B.} and Watson, {J. Tracy} and Michael McKee and Ammar Karim and Michael Talerico and Sietsema, {Debra L.} and Alyse Williams and Tayler Dykes and Obremskey, {William T.} and Jahangir, {Amir Alex} and Manish Sethi and Robert Boyce and Stinner, {Daniel J.} and Phillip Mitchell and Karen Trochez and Andres Rodriguez and Vamshi Gajari and Elsa Rodriguez and Charles Pritchett and Christina Boulton",
note = "Funding Information: The Aqueous-PREP trial is funded by the US Department of Defense (W81XWH-17-1-070) and the CIHR (Foundation Grant). McMaster University Surgical Associates funded start-up activities at the Methods Center and The Physician Services Incorporated provided funding to the Methods Center and Hamilton Health Sciences for the Aqueous-PREP trial. Study funders have no role in the study design, collection, management, analysis, and interpretation of data. Publisher Copyright: {\textcopyright} 2021, The Author(s).",
year = "2021",
month = dec,
doi = "10.1186/s40814-021-00800-8",
language = "English",
volume = "7",
journal = "Pilot and Feasibility Studies",
issn = "2055-5784",
number = "1",
}