Trial of Vancomycin and Cefazolin as Surgical Prophylaxis in Arthroplasty

医学 头孢唑林 安慰剂 关节置换术 万古霉素 外科 置信区间 相对风险 预防性抗生素 不利影响 随机化 化学预防 麻醉 随机对照试验 金黄色葡萄球菌 内科学 抗生素 替代医学 细菌 病理 微生物学 生物 遗传学
作者
Trisha Peel,Sarah Astbury,Allen C. Cheng,David L. Paterson,Kirsty Buising,Tim Spelman,An Tran‐Duy,Sam Adie,Glenn Boyce,Catherine McDougall,Robert Molnar,Jonathan Mulford,Peter Rehfisch,Michael Solomon,Ross Crawford,Tiffany Harris‐Brown,Janine Roney,Jessica A. Wisniewski,Richard de Steiger
出处
期刊:The New England Journal of Medicine [Massachusetts Medical Society]
卷期号:389 (16): 1488-1498 被引量:33
标识
DOI:10.1056/nejmoa2301401
摘要

The addition of vancomycin to beta-lactam prophylaxis in arthroplasty may reduce surgical-site infections; however, the efficacy and safety are unclear. Download a PDF of the Research Summary. 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. 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). 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.) QUICK TAKE VIDEO SUMMARYVancomycin and Cefazolin Prophylaxis in Arthroplasty 02:01
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