近日，英国约克大学教授Emily Packer团队比较了英国负压伤口治疗与常规护理在二次手术伤口愈合患者中的疗效。相关论文发表在2025年4月15日出版的《柳叶刀》杂志上。

手术伤口继发性愈合（SWHSI）提出了重大的管理和财政挑战。负压伤口治疗（NPWT）越来越多地被用作一种治疗方法，尽管缺乏有效性的比较证据。研究组评估了NPWT与常规护理相比在改善SWHSI患者伤口愈合时间方面的有效性。

研究组在29个英国国家卫生服务信托基金中进行了一项实用的、开放标签的、多中心的、平行组的、随机对照试验。年龄在16岁或以上且SWHSI适合两种研究治疗（NPWT或常规护理）的参与者通过集中的基于网络的系统随机分配（1:1）。随机分组按伤口位置、伤口面积和研究中心分层。参与者被随访了12个月。参与者、临床和研究团队不能对治疗隐瞒。负责治疗的评估人员检查了伤口照片以验证结果。主要终点是伤口愈合时间（从随机化到上皮完全覆盖的天数），通过Kaplan-Meier生存曲线和比例风险Cox回归模型进行治疗意向分析。该试验已在ISRCTN注册，注册号为ISRCTN26277546。

2019年5月15日至2023年1月13日，686名SWHSI患者被随机分配接受NPWT （n=349）或常规护理（n=337）。所有参与者均纳入初步分析。大多数参与者为糖尿病患者（n=549, 80.00%），并且在血管手术后出现单一SWHSI （n=622, 90.07%），位于足部或腿部（n=620, 90.04%）。没有明确的证据表明NPWT与常规护理相比减少了伤口愈合时间（风险比1.08，p= 0.47）。共有448例不良事件，其中14例为严重不良事件（NPWT组9例，常规护理组5例）；124例被认为可能与治疗有关。与常规护理相比，NPWT并不具有成本效益。

研究结果表明，在下肢SWHSI患者中，包括伴有糖尿病并发症的患者，没有明确的证据表明与标准敷料相比，NPWT减少了伤口愈合时间。这些发现不支持使用NPWT来增强SWHSI的愈合。

附：英文原文

Title: Negative pressure wound therapy versus usual care in patients with surgical wound healing by secondary intention in the UK (SWHSI-2): an open-label, multicentre, parallel-group, randomised controlled trial

Author: Catherine Arundel, Laura Mandefield, Caroline Fairhurst, Kalpita Baird, Athanasios Gkekas, Pedro Saramago, Ian Chetter, Belen Corbacho Martin, Catherine E Hewitt, Andrew Mott, Samantha Swan, David J Torgerson, Jacqueline Wilkinson, Sabeen Zahra, Jane Blazeby, Rhiannon Macefield, Stephen Dixon, Josie Hatfield, Angela Oswald, Jo Dumville, Matthew Lee, Thomas Pinkney, Nikki Stubbs, Lyn Wilson, Annie Clothier, David C Bosanquet, Melissa Blow, Claire Price, Jackie Todd, Tracey Munro, Woolagasen Pillay, Aniket Pradhan, Andrew Garnham, Michael Wall, Katarzyna Powezka, Arooj Syed, David Gerrard, Andrea Croucher, Nansi Hadjievangelou, Anna Firth, Tracey Roe, George Smith, Colin Bicknell, Caitlin Carr, Esther Negbenose, Lawrence. Tarusan, Alex Vesey, Debbie Wilson, Dina Bell, Joanne Fletcher, Clare Greenwood, Tom Wallace, Srinivasa Vallabhaneni, Sophie Holder, Julie Williams, Steven Sim, Andrew L Tambyraja, Fiona Kerray, Aaron Ng, Martin Sylvester, Lynda Slater, S Tawqeer Rashid, April Palacios, Kornelia Feld, Sandip Nandhra, Gerard Stansby, Noala Parr, Louise Jones, Jeanette Milne, Caroline Stubbs, Robert Hinchliffe, Christopher Twine, Georgios A Antoniou, Carolyn Corbett, Sheila Munt, Sarah Warran, Rachel Fletcher, Wissam Al-Jundi, Mandy Burrows, Philip Stather, Rachel Barnes, Tania Woodrow, Benita Adams, Obiekezie Agu, Yvonne Gleeson, Rovan DSouza, Leanna Erete, Steven Jones, Clare Checketts, Dani Bajic, Robert Matravers, Ian Loftus, James Budge, Bilal Azhar, Rebecca Hancox, Cheri Pearce, Nigel Suggett, Arlo Whitehouse, Maciej Juszczak, Ganesh Kuhan, Sivaram Premnath, Nikesh Dattani, Vanessa Hollings, Farah Khasawneh, Julien AlShakarchi, Emily Packer

Issue&Volume: 2025-04-15

Abstract: Background

Surgical wound healing by secondary intention (SWHSI) presents a substantial management and financial challenge. Negative pressure wound therapy (NPWT) has increasingly been used as a treatment despite an absence of comparative evidence of effectiveness. We evaluated the effectiveness of NPWT compared with usual care for improving time to wound healing in patients with an SWHSI.

Methods

We did a pragmatic, open-label, multicentre, parallel-group, randomised controlled trial in 29 UK National Health Service Trusts. Participants aged 16 years or older with an SWHSI appropriate for both study treatments (NPWT or usual care) were randomly assigned (1:1) by a centralised web-based system. Randomisation was stratified by wound location, wound area, and study centre. Participants were followed up for 12 months. Participants and clinical and research teams could not be masked to treatment. Assessors masked to treatment reviewed wound photography to verify the outcome. The primary outcome was time to wound healing (days from randomisation to complete epithelial cover), analysed via intention to treat using Kaplan–Meier survival curves and a proportional hazards Cox regression model. The trial was registered with ISRCTN, ISRCTN26277546.

Findings

Between May 15, 2019, and Jan 13, 2023, 686 participants with an SWHSI were randomly assigned to receive NPWT (n=349) or usual care (n=337). All participants were included in the primary analysis. Most participants were diabetic (n=549, 80·0%) and had a single SWHSI (n=622, 90·7%), located on the foot or leg (n=620, 90·4%), arising after vascular surgery (n=619, 90·2%). There was no clear evidence that NPWT reduced the time to wound healing compared with usual care (hazard ratio 1·08 [95% CI 0·88–1·32], p=0·47). There were 448 adverse events, of which 14 were serious (nine participants in the NPWT group and five participants in the usual care group); 124 were deemed potentially related to treatment. NPWT was found not to be cost-effective compared with usual care.

Interpretation

In patients with a lower limb SWHSI, including those with complications of diabetes, there is no clear evidence that NPWT reduced the time to wound healing compared with standard dressings. These findings do not support the use of NPWT to augment SWHSI healing.

DOI: 10.1016/S0140-6736(25)00143-6

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00143-6/abstract