Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences, Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
Bone Joint J. 2021 Apr;103-B(4):755-761. doi: 10.1302/0301-620X.103B4.BJJ-2020-1603.R1.
This study sought to compare the rate of deep surgical site infection (SSI), as measured by the Centers for Disease Control and Prevention (CDC) definition, after surgery for a fracture of the hip between patients treated with standard dressings and those treated with incisional negative pressure wound therapy (iNPWT). Secondary objectives included determining the rate of recruitment and willingness to participate in the trial.
The study was a two-arm multicentre randomized controlled feasibility trial that was embedded in the World Hip Trauma Evaluation cohort study. Any patient aged > 65 years having surgery for hip fracture at five recruitment centres in the UK was considered to be eligible. They were randomly allocated to have either a standard dressing or iNPWT after closure of the wound. The primary outcome measure was deep SSI at 30 and 90 days, diagnosed according to the CDC criteria. Secondary outcomes were: rate of recruitment; further surgery within 120 days; health-related quality of life (HRQoL) using the EuroQol five-level five-dimension questionnaire (EQ-5D-5L); and related complications within 120 days as well as mobility and residential status at this time.
A total of 462 valid randomizations were carried out (232 and 230 in the standard dressing and iNPWT groups, respectively). In the standard dressing group, 14 of 218 patients (6.4%) developed deep SSI. In the iNPWT group, four of 214 patients (1.9%) developed deep SSI. This gives a total rate of SSI of 4.2% (95% confidence interval (CI) 2.7% to 6.5%). Patients and surgeons were willing to participate in the study with 462 patients being recruited from a possible 749 (62.3%).
The rate of deep SSI 30 days after surgery for a fracture of the hip was 4%, which makes a study comparing the clinical effectiveness of standard dressings and iNPWT feasible. Cite this article: 2021;103-B(4):755-761.
本研究旨在比较采用美国疾病控制与预防中心（CDC）定义的深部手术部位感染（SSI）发生率，比较接受标准敷料和切口负压伤口治疗（iNPWT）的髋部骨折患者的手术治疗结果。次要目标包括确定招募率和参与试验的意愿。
本研究是一项两臂多中心随机对照可行性试验，嵌入 World Hip Trauma Evaluation 队列研究中。英国五个招募中心的任何年龄>65 岁、接受髋关节骨折手术的患者均符合入组条件。他们在伤口闭合后随机分配接受标准敷料或 iNPWT。主要结局测量指标为 30 天和 90 天的深部 SSI，根据 CDC 标准诊断。次要结局包括：招募率；120 天内再次手术；采用 EuroQol 五维五度问卷（EQ-5D-5L）评估健康相关生活质量（HRQoL）；120 天内的相关并发症以及此时的活动能力和居住状况。
共进行了 462 例有效随机分组（标准敷料组 218 例，iNPWT 组 214 例）。标准敷料组 218 例患者中，14 例（6.4%）发生深部 SSI；iNPWT 组 214 例患者中，4 例（1.9%）发生深部 SSI。总的 SSI 发生率为 4.2%（95%置信区间（CI）2.7%至 6.5%）。患者和外科医生愿意参与研究，从可能的 749 例患者中招募了 462 例（62.3%）。
髋部骨折手术后 30 天深部 SSI 的发生率为 4%，这使得比较标准敷料和 iNPWT 临床疗效的研究成为可能。
