Department of Orthopaedics, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore.
Department of Infectious Diseases, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore.
JAMA Surg. 2021 May 1;156(5):e207259. doi: 10.1001/jamasurg.2020.7259. Epub 2021 May 12.
Despite the widespread use of systemic antibiotics to prevent infections in surgically treated patients with fracture, high rates of surgical site infection persist.
To examine the effect of intrawound vancomycin powder in reducing deep surgical site infections.
DESIGN, SETTING, AND PARTICIPANTS: This open-label randomized clinical trial enrolled adult patients with an operatively treated tibial plateau or pilon fracture who met the criteria for a high risk of infection from January 1, 2015, through June 30, 2017, with 12 months of follow-up (final follow-up assessments completed in April 2018) at 36 US trauma centers.
A standard infection prevention protocol with (n = 481) or without (n = 499) 1000 mg of intrawound vancomycin powder.
The primary outcome was a deep surgical site infection within 182 days of definitive fracture fixation. A post hoc comparison assessed the treatment effect on gram-positive and gram-negative-only infections. Other secondary outcomes included superficial surgical site infection, nonunion, and wound dehiscence.
The analysis included 980 patients (mean [SD] age, 45.7 [13.7] years; 617 [63.0%] male) with 91% of the expected person-time of follow-up for the primary outcome. Within 182 days, deep surgical site infection was observed in 29 of 481 patients in the treatment group and 46 of 499 patients in the control group. The time-to-event estimated probability of deep infection by 182 days was 6.4% in the treatment group and 9.8% in the control group (risk difference, -3.4%; 95% CI, -6.9% to 0.1%; P = .06). A post hoc analysis of the effect of treatment on gram-positive (risk difference, -3.7%; 95% CI, -6.7% to -0.8%; P = .02) and gram-negative-only (risk difference, 0.3%; 95% CI, -1.6% to 2.1%; P = .78) infections found that the effect of vancomycin powder was a result of its reduction in gram-positive infections.
Among patients with operatively treated tibial articular fractures at a high risk of infection, intrawound vancomycin powder at the time of definitive fracture fixation reduced the risk of a gram-positive deep surgical site infection, consistent with the activity of vancomycin.
ClinicalTrials.gov Identifier: NCT02227446.
尽管在接受手术治疗的骨折患者中广泛使用全身性抗生素来预防感染，但手术部位感染的发生率仍然很高。
研究局部使用万古霉素粉末减少深部手术部位感染的效果。
设计、地点和参与者：这项开放性标签随机临床试验纳入了 2015 年 1 月 1 日至 2017 年 6 月 30 日期间接受手术治疗的胫骨平台或 pilon 骨折的成年患者，这些患者符合感染高风险标准，随访 12 个月（最终随访评估于 2018 年 4 月完成），在美国 36 个创伤中心进行。
标准感染预防方案（n=481）或不使用（n=499）局部 1000mg 万古霉素粉末。
主要结局为在确定性骨折固定后 182 天内发生深部手术部位感染。事后比较评估了万古霉素粉末对革兰氏阳性和革兰氏阴性感染的治疗效果。其他次要结局包括浅表手术部位感染、骨不连和伤口裂开。
分析纳入了 980 名患者（平均[标准差]年龄 45.7[13.7]岁；617[63.0%]为男性），主要结局的预期随访时间为 91%。在 182 天内，治疗组 481 名患者中有 29 名和对照组 499 名患者中有 46 名发生深部手术部位感染。治疗组 182 天内深部感染的时间事件估计概率为 6.4%，对照组为 9.8%（风险差异，-3.4%；95%置信区间，-6.9%至 0.1%；P=0.06）。对治疗对革兰氏阳性（风险差异，-3.7%；95%置信区间，-6.7%至-0.8%；P=0.02）和仅革兰氏阴性（风险差异，0.3%；95%置信区间，-1.6%至 2.1%；P=0.78）感染的影响的事后分析发现，万古霉素粉末的作用是降低了革兰氏阳性感染的风险。
在接受手术治疗的高感染风险胫骨关节骨折患者中，在确定性骨折固定时局部使用万古霉素粉末可降低革兰氏阳性深部手术部位感染的风险，这与万古霉素的活性一致。
ClinicalTrials.gov 标识符：NCT02227446。
