Masters James P M, Achten Juul, Cook Jonathan, Dritsaki Melina, Sansom Lucy, Costa Matthew L
Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.
Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.
BMJ Open. 2018 Apr 12;8(4):e020632. doi: 10.1136/bmjopen-2017-020632.
Deep wound infection is a catastrophic complication after hip fracture surgery. However, current understanding of infection rates in this population is limited. Many technologies such as incisional negative-pressure wound therapy (NPWT) show promise in reducing the rate of infection. This trial is a feasibility study looking to establish a value estimated with a greater precision of the rate of deep infection after hip fracture treatment in patients treated with NPWT versus standard dressing following hip fracture surgery.
A randomised controlled trial of 464 patients will be run across multiple centres. It is embedded in the World Hip Trauma Evaluation cohort study. Any patient over the age of 65 years having surgery for hip fracture is eligible unless they are being treated with percutaneous screw fixation. A web-based randomisation sequence will stratify patients by centre. Patients will be allocated to either NPWT or standard care on a 1:1 basis. The primary outcome measure is the Centre for Disease Control definition of deep infection at 30 days. Follow-up at 4 months will also assess deep infection and the core outcome dataset for hip fractures. This includes health-related quality of life (EQ-5D-5L), mobility, mortality and late complications such as further surgery. The primary analysis will be intention to treat.
Oxford C Research Ethics Committee granted ethical approval on 28/04/2017, 17/SC/0207. The results of this study will be reported in a peer-reviewed publication and inform the design of a future full-scale trial.
ISRCTN55305726.
深部伤口感染是髋部骨折手术后的灾难性并发症。然而，目前对该人群感染率的了解有限。许多技术，如切口负压伤口治疗（NPWT），在降低感染率方面显示出前景。本试验是一项可行性研究，旨在更精确地估计接受NPWT治疗的髋部骨折患者与接受髋部骨折手术后标准敷料治疗的患者深部感染率的估计值。
将在多个中心对464名患者进行一项随机对照试验。它被纳入世界髋部创伤评估队列研究。任何65岁以上接受髋部骨折手术的患者均符合条件，除非他们正在接受经皮螺钉固定治疗。基于网络的随机序列将按中心对患者进行分层。患者将按1:1的比例分配到NPWT组或标准护理组。主要结局指标是疾病控制中心对30天时深部感染的定义。4个月时的随访还将评估深部感染以及髋部骨折的核心结局数据集。这包括与健康相关的生活质量（EQ-5D-5L）、 mobility、死亡率和晚期并发症，如进一步手术。主要分析将采用意向性分析。
牛津C研究伦理委员会于
2017年4月28日批准了伦理许可，编号为17/SC/0207。本研究结果将在同行评审的出版物上发表，并为未来大规模试验的设计提供参考。
ISRCTN55305726。
