Trial of Vancomycin and Cefazolin as Surgical Prophylaxis in Arthroplasty
- Author(s)
- Peel, TN; Astbury, S; Cheng, AC; Paterson, DL; Buising, KL; Spelman, T; Tran-Duy, A; Adie, S; Boyce, G; McDougall, C; Molnar, R; Mulford, J; Rehfisch, P; Solomon, M; Crawford, R; Harris-Brown, T; Roney, J; Wisniewski, J; de Steiger, R; ASAP Trial Group;
- Details
- Publication Year 2023-10-19,Volume 389,Issue #16,Page 1488-1498
- Journal Title
- New England Journal of Medicine
- Publication Type
- Research article
- Abstract
- BACKGROUND: The addition of vancomycin to beta-lactam prophylaxis in arthroplasty may reduce surgical-site infections; however, the efficacy and safety are unclear. METHODS: In this multicenter, double-blind, superiority, placebo-controlled trial, we randomly assigned adult patients without known methicillin-resistant Staphylococcus aureus (MRSA) colonization who were undergoing arthroplasty to receive 1.5 g of vancomycin or normal saline placebo, in addition to cefazolin prophylaxis. The primary outcome was surgical-site infection within 90 days after surgery. RESULTS: A total of 4239 patients underwent randomization. Among 4113 patients in the modified intention-to-treat population (2233 undergoing knee arthroplasty, 1850 undergoing hip arthroplasty, and 30 undergoing shoulder arthroplasty), surgical-site infections occurred in 91 of 2044 patients (4.5%) in the vancomycin group and in 72 of 2069 patients (3.5%) in the placebo group (relative risk, 1.28; 95% confidence interval [CI], 0.94 to 1.73; P = 0.11). Among patients undergoing knee arthroplasty, surgical-site infections occurred in 63 of 1109 patients (5.7%) in the vancomyin group and in 42 of 1124 patients (3.7%) in the placebo group (relative risk, 1.52; 95% CI, 1.04 to 2.23). Among patients undergoing hip arthroplasty, surgical-site infections occurred in 28 of 920 patients (3.0%) in the vancomyin group and in 29 of 930 patients (3.1%) in the placebo group (relative risk, 0.98; 95% CI, 0.59 to 1.63). Adverse events occurred in 35 of 2010 patients (1.7%) in the vancomycin group and in 35 of 2030 patients (1.7%) in the placebo group, including hypersensitivity reactions in 24 of 2010 patients (1.2%) and 11 of 2030 patients (0.5%), respectively (relative risk, 2.20; 95% CI, 1.08 to 4.49), and acute kidney injury in 42 of 2010 patients (2.1%) and 74 of 2030 patients (3.6%), respectively (relative risk, 0.57; 95% CI, 0.39 to 0.83). CONCLUSIONS: The addition of vancomycin to cefazolin prophylaxis was not superior to placebo for the prevention of surgical-site infections in arthroplasty among patients without known MRSA colonization. (Funded by the Australian National Health and Medical Research Council; Australian New Zealand Clinical Trials Registry number, ACTRN12618000642280.).
- Publisher
- Massachusetts Medical Society
- Keywords
- Adult; Humans; *Anti-Bacterial Agents/adverse effects/therapeutic use; *Antibiotic Prophylaxis/adverse effects/methods; Arthroplasty, Replacement, Knee/adverse effects/methods; Australia; *Cefazolin/adverse effects/therapeutic use; Methicillin-Resistant Staphylococcus aureus; Staphylococcal Infections/epidemiology/prevention & control/drug therapy; *Surgical Wound Infection/epidemiology/prevention & control/etiology; *Vancomycin/adverse effects/therapeutic use; Double-Blind Method; *Arthroplasty, Replacement/adverse effects/methods/statistics & numerical data
- Department(s)
- Health Services Research
- PubMed ID
- 37851875
- Publisher's Version
- https://doi.org/10.1056/NEJMoa2301401
- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2023-12-05 12:35:40
Last Modified: 2024-07-16 04:18:36