Backes Manouk, Dingemans Siem A, Dijkgraaf Marcel G W, van den Berg H Rogier, van Dijkman Bart, Hoogendoorn Jochem M, Joosse Pieter, Ritchie Ewan D, Roerdink W Herbert, Schots Judith P M, Sosef Nico L, Spijkerman Ingrid J B, Twigt Bas A, van der Veen Alexander H, van Veen Ruben N, Vermeulen Jefrey, Vos Dagmar I, Winkelhagen Jasper, Goslings J Carel, Schepers Tim
Trauma Unit, Department of Surgery, Academic Medical Center Amsterdam, the Netherlands.
Clinical Research Unit, Academic Medical Center, Amsterdam, the Netherlands.
JAMA. 2017 Dec 26;318(24):2438-2445. doi: 10.1001/jama.2017.19343.
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.
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.
A single preoperative intravenous dose of 1000 mg of cefazolin (cefazolin group, n = 228) or sodium chloride (0.9%; saline group, n = 242).
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.
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).
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.
clinicaltrials.gov Identifier: NCT02225821.
在进行清洁（I类，未污染）外科手术后，手术部位感染（SSI）率应低于约2%。然而，据报道，用于治疗膝以下骨折的骨科植入物取出术后感染率为12.2%。
评估术前单次预防性使用抗生素对用于治疗膝以下骨折的骨科植入物取出术后手术部位感染发生率的影响。
设计、地点和参与者：多中心、双盲、随机临床试验，纳入500例年龄在18至75岁之间、既往接受过膝以下骨折手术治疗且正在荷兰19家医院（17家教学医院和2家学术医院）接受骨科植入物取出术的患者（2014年11月至2016年9月），随访6个月（最终随访时间为2017年3月28日）。排除标准为存在活动性感染或瘘管、正在接受抗生素治疗、在同一手术中再次植入骨合成材料、对头孢菌素过敏、已知患有肾脏疾病、正在使用免疫抑制剂或怀孕。
术前静脉单次注射1000mg头孢唑林（头孢唑林组，n = 228）或氯化钠（0.9%；生理盐水组，n = 242）。
主要结局是根据美国疾病控制与预防中心的标准测量的30天内手术部位感染。次要结局指标包括功能结局、健康相关生活质量和患者满意度。
在477例随机分组的患者中（平均年龄44岁[标准差15]；女性274例[57%]；骨科植入物置入后的中位时间为11个月[四分位间距7 - 16]），470例患者完成了研究。66例患者发生了手术部位感染（14.0%）：头孢唑林组30例（13.2%），生理盐水组36例（14.9%）（绝对风险差异为 -1.7[95%置信区间，-8.0至4.6]，P = 0.60）。
在接受用于治疗膝以下骨折的骨科植入物取出术的患者中，术前单次静脉注射头孢唑林与注射生理盐水相比，并未降低植入物取出后30天内手术部位感染的风险。
clinicaltrials.gov标识符：NCT02225821。
