1. Skin Antisepsis before Surgical Fixation of Extremity Fractures.
- Author
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Sprague S, Slobogean G, Wells JL, O'Hara NN, Thabane L, Mullins CD, Harris AD, Wood A, Viskontas D, Apostle KL, O'Toole RV, Joshi M, Johal H, Al-Asiri J, Hymes RA, Gaski GE, Pilson HT, Carroll EA, Babcock S, Halvorson JJ, Romeo NM, Matson CA, Higgins TF, Marchand LS, Bergin PF, Morellato J, Van Demark RE 3rd, Potter GD, Gitajn IL, Chang G, Phelps KD, Kempton LB, Karunakar M, Jaeblon T, Demyanovich HK, Domes CM, Kuhn GR, Reilly RM, Gage MJ, Weaver MJ, von Keudell AG, Heng M, McTague MF, Alnasser A, Mehta S, Donegan DJ, Natoli RM, Szatkowski J, Scott AN, Shannon SF, Jeray KJ, Tanner SL, Marmor MT, Matityahu A, Fowler JT, Pierrie SN, Beltran MJ, Thomson CG, Lin CA, Moon CN, Scolaro JA, Amirhekmat A, Leonard J, Pogorzelski D, Bzovsky S, Heels-Ansdell D, Szasz OP, Gallant JL, Della Rocca GJ, Zura RD, Hebden JN, Patterson JT, Lee C, O'Hara LM, Marvel D, Palmer JE, Friedrich J, D'Alleyrand JG, Rivera JC, Mossuto F, Schrank GM, Guyatt G, Devereaux PJ, and Bhandari M
- Subjects
- Humans, 2-Propanol administration & dosage, 2-Propanol adverse effects, 2-Propanol therapeutic use, Antisepsis methods, Canada, Ethanol, Extremities injuries, Extremities microbiology, Extremities surgery, Preoperative Care adverse effects, Preoperative Care methods, Skin microbiology, Cross-Over Studies, United States, Anti-Infective Agents, Local administration & dosage, Anti-Infective Agents, Local adverse effects, Anti-Infective Agents, Local therapeutic use, Chlorhexidine administration & dosage, Chlorhexidine adverse effects, Chlorhexidine therapeutic use, Iodine administration & dosage, Iodine adverse effects, Iodine therapeutic use, Surgical Wound Infection etiology, Surgical Wound Infection prevention & control, Fractures, Bone surgery, Fracture Fixation
- Abstract
Background: Studies 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)., Methods: In 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., Results: A 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., Conclusions: Among 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.)
- Published
- 2024
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