Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England.
Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England.
JAMA. 2020 Feb 11;323(6):519-526. doi: 10.1001/jama.2020.0059.
Following surgery to treat major trauma-related fractures, deep wound infection rates are high. It is not known if negative pressure wound therapy can reduce infection rates in this setting.
To assess outcomes in patients who have incisions resulting from surgery for lower limb fractures related to major trauma and were treated with either incisional negative pressure wound therapy or standard wound dressing.
DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial conducted at 24 trauma hospitals representing the UK Major Trauma Network that included 1548 patients aged 16 years or older who underwent surgery for a lower limb fracture caused by major trauma from July 7, 2016, through April 17, 2018, with follow-up to December 11, 2018.
Incisional negative pressure wound therapy (n = 785), which involved a specialized dressing used to create negative pressure over the wound, vs standard wound dressing not involving negative pressure (n = 763).
The primary outcome measure was deep surgical site infection at 30 days diagnosed according to the criteria from the US Centers for Disease Control and Prevention. A preplanned secondary analysis of the primary outcome was performed at 90 days. The secondary outcomes were patient-reported disability (Disability Rating Index), health-related quality of life (EuroQol 5-level EQ-5D), surgical scar assessment (Patient and Observer Scar Assessment Scale), and chronic pain (Douleur Neuropathique Questionnaire) at 3 and 6 months, as well as other local wound healing complications at 30 days.
Among 1548 participants who were randomized (mean [SD] age, 49.8 [20.3] years; 561 [36%] were aged ≤40 years; 583 [38%] women; and 881 [57%] had multiple injuries), 1519 (98%) had data available for the primary outcome. At 30 days, deep surgical site infection occurred in 5.84% (45 of 770 patients) of the incisional negative pressure wound therapy group and in 6.68% (50 of 749 patients) of the standard wound dressing group (odds ratio, 0.87 [95% CI, 0.57 to 1.33]; absolute risk difference, -0.77% [95% CI, -3.19% to 1.66%]; P = .52). There was no significant difference in the deep surgical site infection rate at 90 days (11.4% [72 of 629 patients] in the incisional negative pressure wound therapy group vs 13.2% [78 of 590 patients] in the standard wound dressing group; odds ratio, 0.84 [95% CI, 0.59 to 1.19]; absolute risk difference, -1.76% [95% CI, -5.41% to 1.90%]; P = .32). For the 5 prespecified secondary outcomes reported, there were no significant differences at any time point.
Among patients who underwent surgery for major trauma-related lower limb fractures, use of incisional negative pressure wound therapy, compared with standard wound dressing, resulted in no significant difference in the rate of deep surgical site infection. The findings do not support the use of incisional negative pressure wound therapy in this setting, although the event rate at 30 days was lower than expected.
isrctn.org Identifier: ISRCTN12702354.
重要性：在治疗与重大创伤相关的骨折的手术后，深部伤口感染率很高。目前尚不清楚负压伤口治疗是否可以降低这种情况下的感染率。
目的：评估接受下肢骨折手术治疗的患者的结局，这些骨折是由重大创伤引起的，采用切口负压伤口治疗或标准伤口敷料进行治疗。
设计、地点和参与者：一项在英国重大创伤网络的 24 家创伤医院进行的随机临床试验，纳入了 1548 名年龄在 16 岁及以上的患者，他们因重大创伤导致下肢骨折接受手术，随访至 2018 年 12 月 11 日。从 2016 年 7 月 7 日至 2018 年 4 月 17 日。
干预措施：切口负压伤口治疗（n = 785），涉及使用专门的敷料在伤口上产生负压，与不涉及负压的标准伤口敷料（n = 763）。
主要结果和措施：主要结局测量指标是根据美国疾病控制与预防中心的标准诊断的 30 天深部手术部位感染。对主要结局进行了预先计划的次要分析，分析时间为 90 天。次要结局是患者报告的残疾（残疾评定指数）、健康相关生活质量（欧洲五维健康量表 5 级 EQ-5D）、手术疤痕评估（患者和观察者疤痕评估量表）和慢性疼痛（神经病理性疼痛问卷）在 3 个月和 6 个月，以及其他 30 天的局部伤口愈合并发症。
结果：在 1548 名随机分组的参与者中（平均[标准差]年龄为 49.8[20.3]岁；≤40 岁的 561 人[36%]；583 名女性[38%]；881 人[57%]有多发性损伤），1519 人（98%）有主要结局的可用数据。在 30 天，切口负压伤口治疗组中深部手术部位感染发生率为 5.84%（770 名患者中有 45 名），标准伤口敷料组中深部手术部位感染发生率为 6.68%（749 名患者中有 50 名）（比值比，0.87[95%置信区间，0.57 至 1.33]；绝对风险差异，-0.77%[95%置信区间，-3.19% 至 1.66%]；P = .52）。在 90 天，深部手术部位感染率无显著差异（切口负压伤口治疗组 11.4%[629 名患者中有 72 名]，标准伤口敷料组 13.2%[590 名患者中有 78 名]；比值比，0.84[95%置信区间，0.59 至 1.19]；绝对风险差异，-1.76%[95%置信区间，-5.41% 至 1.90%]；P = .32）。对于报告的 5 个预设次要结局，在任何时间点均无显著差异。
结论和相关性：在接受下肢骨折手术治疗的患者中，与标准伤口敷料相比，使用切口负压伤口治疗并未显著降低深部手术部位感染的发生率。研究结果不支持在此种情况下使用切口负压伤口治疗，尽管 30 天的事件发生率低于预期。
试验注册：isrctn.org 标识符：ISRCTN84540115.
