[JAMA最新论文]:预防性抗生素对去除用于治疗足、踝及小腿骨科的骨科植入物后手术部位感染的影响 | 中国病理生理学会危重病医学专业委员会
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Original Investigation

December 26, 2017

Effect of Antibiotic Prophylaxis on Surgical Site Infections Following Removal of Orthopedic Implants Used for Treatment of Foot, Ankle, and Lower Leg Fractures: A Randomized Clinical Trial

Manouk Backes, MD, Siem A. Dingemans, Marcel G. W. Dijkgraaf, et al

JAMA. 2017;318(24):2438-2445. doi:10.1001/jama.2017.19343


Importance 背景

Following clean (class I, not contaminated) surgical procedures, the rate of surgical site infection (SSI) should be less than approximately 2%. However, an infection rate of 12.2% has been reported following removal of orthopedic implants used for treatment of fractures below the knee.


Objective 目的

To evaluate the effect of a single dose of preoperative antibiotic prophylaxis on the incidence of SSIs following removal of orthopedic implants used for treatment of fractures below the knee.


Design, Setting, and Participants 设计,场景及研究对象

Multicenter, double-blind, randomized clinical trial including 500 patients aged 18 to 75 years with previous surgical treatment for fractures below the knee who were undergoing removal of orthopedic implants from 19 hospitals (17 teaching and 2 academic) in the Netherlands (November 2014-September 2016), with a follow-up of 6 months (final follow-up, March 28, 2017). Exclusion criteria were an active infection or fistula, antibiotic treatment, reimplantation of osteosynthesis material in the same session, allergy for cephalosporins, known kidney disease, immunosuppressant use, or pregnancy.


Interventions 干预措施

A single preoperative intravenous dose of 1000 mg of cefazolin (cefazolin group, n = 228) or sodium chloride (0.9%; saline group, n = 242).

术前静脉使用单一剂量头孢唑啉1000 mg(头孢唑啉组,n = 228)或氯化钠(0.9%生理盐水组,n = 242)。

Main Outcomes and Measures 主要预后指标

Primary outcome was SSI within 30 days as measured by the criteria from the US Centers for Disease Control and Prevention. Secondary outcome measures were functional outcome, health-related quality of life, and patient satisfaction.


Results 结果

Among 477 randomized patients (mean age, 44 years [SD, 15]; women, 274 [57%]; median time from orthopedic implant placement, 11 months [interquartile range, 7-16]), 470 patients completed the study. Sixty-six patients developed an SSI (14.0%): 30 patients (13.2%) in the cefazolin group vs 36 in the saline group (14.9%) (absolute risk difference, −1.7 [95% CI, −8.0 to 4.6], P = .60).

477名患者接受随机分组(平均年龄,44岁[SD, 15];女性,274 [57%];从留置骨科植入物至手术时间,11个月 [四分位区间。7-16]),其中470名患者完成试验。66名患者发生SSI (14.0%):头孢唑啉组30 名 (13.2%) ,生理盐水组36名 (14.9%)(绝对风险差异,−1.7 [95% CI, −8.0 to 4.6], P = .60)。

Conclusions and Relevance 结论与意义

Among patients undergoing surgery for removal of orthopedic implants used for treatment of fractures below the knee, a single preoperative dose of intravenous cefazolin compared with saline did not reduce the risk of surgical site infection within 30 days following implant removal.


Trial Registration 试验注册

clinicaltrials.gov Identifier: NCT02225821


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