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Cited by 1Surgical site infection preventionBone fractures and treatmentsOrthopedic Infections and Treatments

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

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O’Hara, Nathan N., Heels-Ansdell, Diane, Bzovsky, Sofia, Dodds, Shannon, Thabane, Lehana, Bhandari, Mohit, Guyatt, Gordon, Devereaux, P. J. +352 more·2022·Trials
DOI 10.1186/s13063-022-06541-0PMC PMC9465853

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Abstract

Background: Approximately 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 design: The 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. Results: The 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. Conclusion: This 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.

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O’Hara, N. N., Heels-Ansdell, D., Bzovsky, S., Dodds, S., Thabane, L., Bhandari, M., Guyatt, G., Devereaux, P. J., Slobogean, G. P., Sprague, S., on behalf of the PREP-IT Investigators, Harris, A. D., Mullins, C. D., Wells, J., Wood, A., Della Rocca, G. J., Hebden, J., Jeray, K. J., Marchand, L. S., O’Hara, L. M., Zura, R., Lee, C., Patterson, J., Gardner, M. J., Blasman, J., Davies, J., Liang, S., Taljaard, M., Thabane, L., Marvel, D., Palmer, J., Friedrich, J., Grissom, F., Gitajn, I. L., Morshed, S., O’Toole, R. V., Petrisor, B. A., Mossuto, F., Joshi, M. G., D’Alleyrand, J.-C., Fowler, J., Rivera, J., Talbot, M., Sprague, S., Pogorzelski, D., Li, S., Rojas, A., Del Fabbro, G., Szasz, O. P., McKay, P., Minea, A., Murphy, K., Howe, A., Demyanovich, H. K., Medeiros, M., Polk, G., Kettering, E., Mahal, N., Eglseder, A., Johnson, A., Langhammer, C., Lebrun, C., Nascone, J., Pensy, R., Pollak, A., Sciadini, M., Degani, Y., Phipps, H., Hempen, E., Johal, H., Ristevski, B., Williams, D., Denkers, M., Rajaratnam, K., Al-Asiri, J., Gallant, J., Pusztai, K., MacRae, S., Renaud, S., Adams, J. D., Beckish, M. L., Bray, C. C., Brown, T. R., Cross, A. W., Dew, T., Faucher, G. K., Gurich, R. W., Lazarus, D. E., Millon, S. J., Palmer, M. J., Porter, S. E., Schaller, T. M., Sridhar, M. S., Sanders, J. L., Rudisill, L. E., Altman, K. M., Quirion, J. C., Loeffler, M. F., Pichiotino, E. R., Cole, A. A., Maltz, E. J., Parker, W., Ramsey, T. B., Burnikel, A., Colello, M., Stewart, R., Wise, J., Moody, M. C., Anderson, M., Eskew, J., Judkins, B., Miller, J. M., Tanner, S. L., Snider, R. G., Bray, E., Abbott, H., Natoli, R. M., McKinley, T. O., Virkus, W. W., Sorkin, A. T., Szatkowski, J. P., Mullis, B. H., Jang, Y., Lopas, L. A., Hill, L. C., Fentz, C. L., Diaz, M. M., Brown, K., Garst, K. M., Denari, E. W., Osborn, P., Pierrie, S., Herrera, M., Miclau, T., Marmor, M., Matityahu, A., McClellan, R. T., Shearer, D., Toogood, P., Ding, A., Murali, J., El Naga, A., Tangtiphaiboontana, J., Belaye, T., Berhaneselase, E., Pokhvashchev, D., Obremskey, W. T., Jahangir, A. A., Sethi, M., Boyce, R., Stinner, D. J., Mitchell, P., Trochez, K., Rodriguez, E., Pritchett, C., Hogan, N., Moreno, A. F., Hagen, J. E., Patrick, M., Vlasak, R., Krupko, T., Talerico, M., Horodyski, M., Koenig, C., Pazik, M., Lossada-Soto, E., Gary, J. L., Warner, S. J., Munz, J. W., Choo, A. M., Achor, T. S., Chip Routt, M. L., Kutzler, M., Boutte, S., Warth, R. J., Prayson, M., Venkatarayappa, I., Horne, B., Jerele, J., Clark, L., Boulton, C., Lowe, J., Ruth, J. T., Askam, B., Seach, A., Cruz, A., Featherston, B., Carlson, R., Romero, I., Zarif, I., Dehghan, N., McKee, M., Sietsema, D. L., Williams, A., Dykes, T., Guerra-Farfan, E., Tomas-Hernandez, J., Teixidor-Serra, J., Molero-Garcia, V., Selga-Marsa, J., Porcel-Vazquez, J. A., Andres-Peiro, J. V., Minguell-Monyart, J., Nuñez-Camarena, J., del Mar Villar-Casares, M., Mestre-Torres, J., Lalueza-Broto, P., Moreira-Borim, F., Garcia-Sanchez, Y., Marcano-Fernández, F., Martínez-Carreres, L., Martí-Garín, D., Serrano-Sanz, J., Sánchez-Fernández, J., Sanz-Molero, M., Carballo, A., Pelfort, X., Acerboni-Flores, F., Alavedra-Massana, A., Anglada-Torres, N., Berenguer, A., Cámara-Cabrera, J., Caparros-García, A., Fillat-Gomà, F., Fuentes-López, R., Garcia-Rodriguez, R., Gimeno-Calavia, N., Martínez-Álvarez, M., Martínez-Grau, P., Pellejero-García, R., Ràfols-Perramon, O., Peñalver, J. M., Domènech, M. S., Soler-Cano, A., Velasco-Barrera, A., Yela-Verdú, C., Bueno-Ruiz, M., Sánchez-Palomino, E., Andriola, V., Molina-Corbacho, M., Maldonado-Sotoca, Y., Gasset-Teixidor, A., Blasco-Moreu, J., Fernández-Poch, N., Rodoreda-Puigdemasa, J., Verdaguer-Figuerola, A., Cueva-Sevieri, H. E., Garcia-Gimenez, S., Viskontas, D. G., Apostle, K. L., Boyer, D. S., Moola, F. O., Perey, B. H., Stone, T. B., Lemke, H. M., Spicer, E., Payne, K., Hymes, R. A., Schwartzbach, C. C., Schulman, J. E., Malekzadeh, A. S., Holzman, M. A., Gaski, G. E., Wills, J., Ahn, J. S., Das, S., English, A. D., Cuff, J. A. N., Pilson, H., Carroll, E. A., Halvorson, J. J., Babcock, S., Goodman, J. B., Holden, M. B., Williams, W., Hill, T., Brotherton, A., Romeo, N. M., Vallier, H. A., Fraifogl, J., Vergon, A., Higgins, T. F., Haller, J. M., Rothberg, D. L., Neese, A., Olsen, Z. M., McGowan, A. V., Hill, S., Dauk, M. K., Bergin, P. F., Russell, G. V., Graves, M. L., Morellato, J., McGee, S. L., Bhanat, E. L., Yener, U., Khanna, R., Nehete, P., Potter, D., VanDemark, R., Atkins, K., Coe, M., Dwyer, K., Mullin, D. S., Chockbengboun, T. A., Phelps, K., Bosse, M., Karunakar, M., Kempton, L., Sims, S., Hsu, J., Seymour, R., Churchill, C., Mayfield, A., Sweeney, J., Jaeblon, T., Beer, R., Bauer, B., Meredith, S., Benzel, C., Domes, C. M., Reilly, R. M., Paniagua, A., Dupree, J. N., Weaver, M. J., von Keudell, A. G., Sagona, A. E., Mehta, S., Donegan, D., Horan, A., Dooley, M., Heng, M., Harris, M. B., Lhowe, D. W., Esposito, J. G., Alnasser, A., Shannon, S. F., Scott, A. N., Clinch, B., Weber, B., Beltran, M. J., Archdeacon, M. T., Sagi, H. C., Wyrick, J. D., Le, T. T., Laughlin, R. T., Thomson, C. G., Hasselfeld, K., Lin, C. A., Vrahas, M. S., Moon, C. N., Little, M. T., Marecek, G. S., Dubuclet, D. M., Scolaro, J. A., Learned, J. R., Lim, P. K., Demas, S., Amirhekmat, A., & Dela Cruz, Y. M.
Affiliations
  • University of Maryland, Baltimore (US)
  • McMaster University (CA)
  • Population Health Research Institute (CA)
ORCID
Venue
Trials
Publisher
Springer Science and Business Media LLC
Published
2022-09-12
Volume
23
Issue
1
Pages
772-772
ISSN
1745-6215 (ISSN-L)
DOI
10.1186/s13063-022-06541-0
PMC
PMC9465853
OpenAlex
W4295242113
Cited by
1
References
34
Citations by year
2022: 1
FWCI
0.24
Type
journal article
Language
en
Open access
Licence
Locations
  • Trials (publishedVersion, cc-by)
  • Research Square (acceptedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
  • U.S. Department of Defense (W81XWH-17-1-070)
  • Canadian Institutes of Health Research
  • McMaster University Surgical Associates
  • The Physician Services Incorporated
Topics
  • Health Sciences › Medicine › Surgery › Surgical site infection prevention
  • Health Sciences › Medicine › Epidemiology › Bone fractures and treatments
  • Health Sciences › Medicine › Surgery › Orthopedic Infections and Treatments
Keywords
open fractures, surgical site infection, povidone-iodine, chlorhexidine, preoperative skin antisepsis
MeSH terms
Anti-Infective Agents, Local, Chlorhexidine, Fractures, Open, Humans, Povidone-Iodine, Surgical Wound Infection, United States, Water

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