TY - JOUR
T1 - Pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solution in open fractures (Aqueous-PREP)
T2 - the feasibility of a cluster randomized crossover study
AU - The PREP-IT Investigators
AU - Sprague, Sheila
AU - Guyatt, Paige
AU - Bzovsky, Sofia
AU - Nguyen, Uyen
AU - Bhandari, Mohit
AU - Thabane, Lehana
AU - Petrisor, Brad
AU - Johal, Herman S.
AU - Leonard, Jordan
AU - Dodds, Shannon
AU - Mossuto, Franca
AU - O’Toole, Robert V.
AU - Howe, Andrea
AU - Demyanovich, Haley K.
AU - Camara, Megan
AU - O’Hara, Nathan N.
AU - Slobogean, Gerard P.
AU - Wells, Jeffrey
AU - D’Alleyrand, Jean Claude
AU - Harris, Anthony D.
AU - Mullins, Daniel C.
AU - Wood, Amber
AU - Della Rocca, Gregory J.
AU - Hebden, Joan
AU - Marchand, Lucas
AU - O’Hara, Lyndsay M.
AU - Zura, Robert
AU - Gardner, Michael J.
AU - Blasman, Jenna
AU - Davies, Jonah
AU - Liang, Stephen
AU - Taljaard, Monica
AU - Devereaux, P. J.
AU - Guyatt, Gordon H.
AU - Heels-Ansdell, Diane
AU - Marvel, Debra
AU - Palmer, Jana
AU - Friedrich, Jeff
AU - Grissom, Ms Frances
AU - Gitajn, I. Leah
AU - Jeray, Kyle J.
AU - Morshed, Saam
AU - Petrisor, Bradley A.
AU - Joshi, Manjari G.
AU - Fowler, Justin
AU - Rivera, Jessica
AU - Talbot, Max
AU - Garibaldi, Alisha
AU - Li, Silvia
AU - Pogorzelski, David
N1 - Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - 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.
AB - 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.
KW - Aqueous antiseptic skin solution
KW - Cluster crossover
KW - Feasibility
KW - Open fractures
KW - Pilot study
KW - Surgical site infection
UR - http://www.scopus.com/inward/record.url?scp=85139850305&partnerID=8YFLogxK
U2 - 10.1186/s40814-021-00800-8
DO - 10.1186/s40814-021-00800-8
M3 - Article
AN - SCOPUS:85139850305
SN - 2055-5784
VL - 7
JO - Pilot and Feasibility Studies
JF - Pilot and Feasibility Studies
IS - 1
M1 - 61
ER -