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Effect of Antibiotic Prophylaxis on Surgical Site Infections Following Removal of Orthopedic Implants Used for Treatment of Foot, Ankle, and Lower Leg Fractures
JAMA ( IF 120.7 ) Pub Date : 2017-12-26 , DOI: 10.1001/jama.2017.19343
Manouk Backes 1 , Siem A. Dingemans 1 , Marcel G. W. Dijkgraaf 2 , H. Rogier van den Berg 3 , Bart van Dijkman 4 , Jochem M. Hoogendoorn 5 , Pieter Joosse 6 , Ewan D. Ritchie 7 , W. Herbert Roerdink 8 , Judith P. M. Schots 9 , Nico L. Sosef 10 , Ingrid J. B. Spijkerman 11 , Bas A. Twigt 12 , Alexander H. van der Veen 9 , Ruben N. van Veen 13 , Jefrey Vermeulen 14 , Dagmar I. Vos 15 , Jasper Winkelhagen 16 , J. Carel Goslings 1 , Tim Schepers 1 ,
Affiliation  

Importance 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 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 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 A single preoperative intravenous dose of 1000 mg of cefazolin (cefazolin group, n = 228) or sodium chloride (0.9%; saline group, n = 242). Main Outcomes and Measures 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 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). Conclusions and Relevance 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 clinicaltrials.gov Identifier: NCT02225821

中文翻译:

抗生素预防对移除用于治疗足部、踝部和小腿骨折的骨科植入物后手术部位感染的影响

重要性 在清洁(I 级,未受污染)外科手术后,手术部位感染 (SSI) 率应低于约 2%。然而,据报道,在移除用于治疗膝盖以下骨折的骨科植入物后,感染率为 12.2%。目的 评估术前预防性使用单剂量抗生素对移除用于治疗膝以下骨折的骨科植入物后 SSI 发生率的影响。设计、设置和参与者 多中心、双盲、随机临床试验,包括 500 名年龄在 18 至 75 岁、既往接受过膝下骨折手术治疗的患者,这些患者来自 19 家医院(17 家教学医院和 2 家学院医院)正在移除骨科植入物荷兰(2014 年 11 月至 2016 年 9 月),随访 6 个月(最终随访,2017 年 3 月 28 日)。排除标准是活动性感染或瘘管、抗生素治疗、在同一疗程中重新植入接骨材料、对头孢菌素过敏、已知肾脏疾病、使用免疫抑制剂或怀孕。干预 术前单次静脉注射 1000 mg 头孢唑啉(头孢唑啉组,n = 228)或氯化钠(0.9%;盐水组,n = 242)。主要结果和测量主要结果是根据美国疾病控制和预防中心的标准测量的 30 天内的 SSI。次要结局指标是功能结局、健康相关的生活质量和患者满意度。结果 在 477 名随机患者中(平均年龄,44 岁 [SD,15];女性,274 [57%];骨科植入物植入的中位时间,11 个月 [四分位距,7-16]),470 名患者完成了研究。66 名患者出现 SSI (14.0%):头孢唑林组 30 名患者 (13.2%) 与生理盐水组 36 名患者 (14.9%)(绝对风险差异,-1.7 [95% CI,-8.0 至 4.6], P = .60)。结论和相关性 在接受手术去除用于治疗膝以下骨折的骨科植入物的患者中,与生理盐水相比,术前单次静脉注射头孢唑林并不能降低植入物去除后 30 天内手术部位感染的风险。试验注册clinicaltrials.gov 标识符:NCT02225821 6],P = .60)。结论和相关性 在接受手术去除用于治疗膝以下骨折的骨科植入物的患者中,与生理盐水相比,术前单次静脉注射头孢唑啉并不能降低植入物去除后 30 天内手术部位感染的风险。试验注册clinicaltrials.gov 标识符:NCT02225821 6],P = .60)。结论和相关性 在接受手术去除用于治疗膝以下骨折的骨科植入物的患者中,与生理盐水相比,术前单次静脉注射头孢唑啉并不能降低植入物去除后 30 天内手术部位感染的风险。试验注册clinicaltrials.gov 标识符:NCT02225821
更新日期:2017-12-26
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