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Randomized Controlled Trial Multicenter Study
Skin Antisepsis before Surgical Fixation of Extremity Fractures.
- PREP-IT Investigators, Sheila Sprague, Gerard Slobogean, Jeffrey L Wells, Nathan N O'Hara, Lehana Thabane, C Daniel Mullins, Anthony D Harris, Amber Wood, Darius Viskontas, Kelly L Apostle, Robert V O'Toole, Manjari Joshi, Herman Johal, Jamal Al-Asiri, Robert A Hymes, Greg E Gaski, Holly T Pilson, Eben A Carroll, Sharon Babcock, Jason J Halvorson, Nicholas M Romeo, Christopher A Matson, Thomas F Higgins, Lucas S Marchand, Patrick F Bergin, John Morellato, Robert E Van Demark, G David Potter, I Leah Gitajn, Gerard Chang, Kevin D Phelps, Laurence B Kempton, Madhav Karunakar, Todd Jaeblon, Haley K Demyanovich, Christopher M Domes, Gabrielle R Kuhn, Rachel M Reilly, Mark J Gage, Michael J Weaver, Arvind G von Keudell, Marilyn Heng, Michael F McTague, Ahmad Alnasser, Samir Mehta, Derek J Donegan, Roman M Natoli, Jan Szatkowski, Alesha N Scott, Steven F Shannon, Kyle J Jeray, Stephanie L Tanner, Meir T Marmor, Amir Matityahu, Justin T Fowler, Sarah N Pierrie, Michael J Beltran, Cameron G Thomson, Carol A Lin, Charles N Moon, John A Scolaro, Arya Amirhekmat, Jordan Leonard, David Pogorzelski, Sofia Bzovsky, Diane Heels-Ansdell, Olivia P Szasz, Jodi L Gallant, Gregory J Della Rocca, Robert D Zura, Joan N Hebden, Joseph T Patterson, Christopher Lee, Lyndsay M O'Hara, Debra Marvel, Jana E Palmer, Jeff Friedrich, D'AlleyrandJean-Claude GJGFrom the Division of Orthopedic Surgery, Department of Surgery (S.S., H.J., J.A.-A., J.L., D.P., S. Bzovsky, O.P.S., J.L.G., M.B.), and the Department of Health Research Methods, Evidence, and Impact (L.T., D.H.-A., G.G.), McMast, Jessica C Rivera, Franca Mossuto, Gregory M Schrank, Gordon Guyatt, P J Devereaux, Mohit Bhandari, and The PREP-IT Investigators.
- From the Division of Orthopedic Surgery, Department of Surgery (S.S., H.J., J.A.-A., J.L., D.P., S. Bzovsky, O.P.S., J.L.G., M.B.), and the Department of Health Research Methods, Evidence, and Impact (L.T., D.H.-A., G.G.), McMaster University, Hamilton Health Sciences Hospital, General Site (F.M.), and the Population Health Research Institute (P.J.D.), Hamilton, ON, and the Department of Orthopedic Surgery, University of British Columbia, Vancouver (D.V., K.L.A.) - all in Canada; the Center for Orthopedic Injury Research and Innovation, Department of Orthopedics, University of Maryland School of Medicine (G.S., N.N.O.), and the Division of Infectious Diseases (M.J.) and the Division of Orthopedic Traumatology, Department of Orthopedics (G.S., M.J.G., R.V.O.), R. Adams Cowley Shock Trauma Center, the Trauma Survivors Network (J.L.W.) and Patient Representative (D.M., J.E.P., J.F.), University of Maryland Baltimore, the University of Maryland School of Pharmacy (C.D.M.), the Departments of Epidemiology and Public Health (A.D.H., J.N.H., L.M.O.) and of Medicine (G.M.S.), University of Maryland School of Medicine, Baltimore, and the Division of Orthopedic Traumatology, Department of Orthopedics, University of Maryland Capital Region Health, Largo (T.J., H.K.D.) - all in Maryland; the Association of periOperative Registered Nurses, Denver (A.W.); the Department of Orthopedic Surgery, Inova Fairfax Medical Campus, Fairfax, VA (R.A.H., G.E.G.); the Department of Orthopedic Surgery and Rehabilitation, Wake Forest University School of Medicine, Winston-Salem (H.T.P., E.A.C., S. Babcock, J.J.H.), the Division of Orthopedic Trauma, Atrium Health, Charlotte (K.D.P., L.B.K., M.K.), and the Department of Orthopedic Surgery, Duke University, Durham (R.M.R.) - all in North Carolina; the Department of Orthopedic Surgery, MetroHealth Medical Center, Cleveland (N.M.R., C.A.M.); the Department of Orthopedic Surgery, University of Utah, Salt Lake City (T.F.H., L.S.M.); the Department of Orthopedic Surgery and Rehabilitation, University of Mississippi Medical Center, Jackson (P.F.B., J.M.); the Division of Orthopedic Surgery, Sanford Health USD Medical Center, Sioux Falls, SD (R.E.V.D.); the Division of Orthopedic Surgery, Northwest Texas Healthcare System, Amarillo (G.D.P.); the Department of Orthopedic Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (I.L.G., G.C.); the Department of Orthopedics and Rehabilitation, University of Wisconsin, Madison (C.M.D., G.R.K.); the Department of Orthopedic Surgery, Brigham and Women's Hospital, Harvard Medical School (M.J.W., A.G.K.), Carl J. Shapiro Department of Orthopedic Surgery, Beth Israel Deaconess Medical Center (M.F.M.), and the Department of Orthopedic Surgery, Harvard Medical School (A. Alnasser) - all in Boston; the Department of Orthopedics, Miller School of Medicine, University of Miami, Miami (M.H.); the Division of Orthopedic Trauma, Department of Orthopedic Surgery, University of Pennsylvania, Philadelphia (S.M., D.J.D.); the Division of Orthopedic Trauma, Department of Orthopedic Surgery, Indiana University School of Medicine, Indianapolis (R.M.N., J.S.); Bryan Health, Lincoln, NE (A.N.S., S.F.S.); the Department of Orthopedic Surgery, Prisma Health-Upstate, Greenville, SC (K.J.J., S.L.T.); the Department of Orthopedic Surgery, University of California, San Francisco, San Francisco (M.T.M., A.M.), the Department of Orthopedic Surgery, Cedars-Sinai Medical Center (C.A.L., C.N.M.), the Department of Orthopedic Surgery, Keck School of Medicine of the University of Southern California (J.T.P.), and the Department of Orthopedic Surgery, UCLA (C.L.), Los Angeles, and the Department of Orthopedic Surgery, University of California, Irvine, Irvine (J.A.S., A. Amirhekmat) - all in California; the Department of Orthopedic Surgery, Brooke Army Medical Center (J.T.F., J.C.R.), and the Department of Orthopedic Surgery, San Antonio Military Medical Center (S.N.P.) - both in Fort Sam Houston, TX; the Department of Orthopedic Surgery and Sports Medicine, University of Cincinnati, Cincinnati (M.J.B.); the Department of Orthopedics, Warren Alpert Medical School, Brown University, Providence, RI (C.G.T.); the Department of Orthopedic Surgery, University of Missouri, Columbia (G.J.D.R.); Louisiana State University Health Sciences Center Orthopedics New Orleans, New Orleans (R.D.Z.); and the Department of Orthopedic Surgery, Landstuhl Regional Medical Center, Landstuhl, Germany (J.-C.G.D.).
- N. Engl. J. Med. 2024 Feb 1; 390 (5): 409420409-420.
BackgroundStudies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture).MethodsIn a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures. Every 2 months, the hospitals alternated interventions. Separate populations of patients with either open or closed fractures were enrolled and included in the analysis. The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for fracture-healing complications.ResultsA total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial. In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P = 0.049). In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd ratio, 0.86; 95% CI, 0.58 to 1.27; P = 0.45). The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events were similar in the two groups.ConclusionsAmong patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.).Copyright © 2024 Massachusetts Medical Society.
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