Effect of Negative Pressure Wound Therapy vs Standard Wound Management on 12-Month Disability Among Adults With Severe Open Fracture of the Lower Limb The WOLLF Randomized Clinical Trial
Effect of Negative Pressure Wound Therapy vs Standard Wound Management on 12-Month Disability Among Adults With Severe Open Fracture of the Lower Limb The WOLLF Randomized Clinical Trial
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DOI：
10.1001/jama.2018.6452
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发表时间：
2018-06-12
影响因子：
120.7
通讯作者：
Parsons, Nick R.
中科院分区：
文献类型：
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作者：
Costa, Matthew L.;Achten, Juul;Parsons, Nick R.
重要提示：当断骨穿透皮肤时，就会发生四肢开放性骨折。目的评估在第一次创伤清创手术后接受负压创伤治疗(NPWT)和标准伤口处理的严重开放性下肢骨折患者的伤残、深度感染率和生活质量。设计、设置和参与者在英国重大创伤网络进行的多中心随机试验，从2012年7月到2015年12月招募了460名年龄在16岁或以上的严重开放性下肢骨折患者。最终结果数据收集到2016年11月。NPWT(n=226)将开放的固体泡沫或纱布放置在伤口表面并连接到吸引泵，在敷料上产生部分真空，与不施加负压的标准敷料(n=234)进行比较。主要结果和测量12个月时的残疾评级指数评分(范围从0[无残疾]到100[完全残疾])是主要的结果测量，临床上最小的重要差异为8分。次要结果是在3、6、9和12个月收集的并发症，包括深度感染和生活质量(评分范围从1[最好的可能]到-0.59[最差的可能]；最小的临床重要差异，0.08)。结果在460名随机分组的患者中(平均年龄45.3岁；74%的男性)，88%(374/427)的可用研究参与者完成了试验。12个月时，患者的残疾分级指数评分差异无统计学意义(NPWT组平均得分45.5分，标准敷料组42.4分；平均差异-3.9[95%CI，-8.9~1.2]；P=.13)，深部手术部位感染个数，NPWT组16例[7.1%]vs标准敷料组19例[8.1%]，差异1.0%[95%CI，-4.2%至6.3%]；P=.64)，或两组间的生活质量差异(EuroQol 5维问卷，0.02[95%CI，-0.05~0.08]；简表-12身体成分评分，0.5[95%CI，-3.1~4.1]和心理健康成分评分，-0.4[95%CI，-2.2~1.4])。结论与标准创面敷料相比，在12个月时，使用NPWT与标准创面敷料相比，并不能改善自评残疾。这些发现并不支持这种治疗严重开放性骨折的方法。
IMPORTANCE Open fractures of the lower limb occur when a broken bone penetrates the skin. There can be major complications from these fractures, which can be life-changing.OBJECTIVES To assess the disability, rate of deep infection, and quality of life in patients with severe open fracture of the lower limb treated with negative pressure wound therapy (NPWT) vs standard wound management after the first surgical debridement of the wound.DESIGN, SETTING, AND PARTICIPANTS Multicenter randomized trial performed in the UK Major Trauma Network, recruiting 460 patients aged 16 years or older with a severe open fracture of the lower limb from July 2012 through December 2015. Final outcome data were collected through November 2016. Exclusions were presentation more than 72 hours after injury and inability to complete questionnaires.INTERVENTIONS NPWT (n = 226) in which an open-cell solid foam or gauze was placed over the surface of the wound and connected to a suction pump, creating a partial vacuum over the dressing, vs standard dressings not involving application of negative pressure (n = 234). MAIN OUTCOMES AND MEASURES Disability Rating Index score (range, 0 [no disability] to 100 [completely disabled]) at 12 months was the primary outcome measure, with a minimal clinically important difference of 8 points. Secondary outcomes were complications including deep infection and quality of life (score ranged from 1 [best possible] to -0.59 [worst possible]; minimal clinically important difference, 0.08) collected at 3, 6, 9, and 12 months.RESULTS Among 460 patients who were randomized (mean age, 45.3 years; 74% men), 88% (374/427) of available study participants completed the trial. There were no statistically significant differences in the patients' Disability Rating Index score at 12 months (mean score, 45.5 in the NPWT group vs 42.4 in the standard dressing group; mean difference, -3.9 [95% CI, -8.9 to 1.2]; P = .13), in the number of deep surgical site infections (16 [7.1%] in the NPWT group vs 19 [8.1%] in the standard dressing group; difference, 1.0%[95% CI, -4.2% to 6.3%]; P = .64), or in quality of life between groups (difference in EuroQol 5-dimensions questionnaire, 0.02 [95% CI, -0.05 to 0.08]; Short Form-12 Physical Component Score, 0.5 [95% CI, -3.1 to 4.1] and Mental Health Component Score, -0.4 [95% CI, -2.2 to 1.4]).CONCLUSIONS AND RELEVANCE Among patients with severe open fracture of the lower limb, use of NPWT compared with standard wound dressing did not improve self-rated disability at 12 months. The findings do not support this treatment for severe open fractures.