Trial reportLancet (London, England)2025
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.
Trial report in Lancet (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and safety of negative pressure wound therapy combined with alginate dressings for wound management: a meta-analysis.Frontiers in medicine · 2026Pooled it
- SWAT 116: the effectiveness of an infographic to improve trial recruitment-a randomised study within a trial (SWAT).Trials · 2026Trial
- Staged Management of Extensive Suprapubic Wound Necrosis After Hysterectomy Using Negative Pressure Wound Therapy and Delayed Skin Grafting.International wound journal · 2026Article
- The role of negative-pressure wound therapy in Fournier's gangrene: Association with mortality.Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES · 2026Article
- Bone‑origin repair in diabetic foot ulcers: Mechanisms of callus formation and endocrine effects in healing (Review).International journal of molecular medicine · 2026Review
- [Analysis of factors influencing tension blister formation on the skin at the dressing edges in patients undergoing negative pressure wound therapy].Zhonghua shao shang yu chuang mian xiu fu za zhi · 2026Article
- Evaluation of the therapeutic value of conventional transpedal lymphography for the treatment of inguinal lymphatic fistulas after lymphadenectomy.CVIR endovascular · 2026Article
- Interventions to Reduce Surgical Site Infection in Transmetatarsal Forefoot Amputations: A Feasibility Survey.International wound journal · 2026Article
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSurgical 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.
methodsWe 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.
findingsBetween 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.
interpretationIn 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.
fundingNational Institute for Health Research Health Technology Assessment Programme.
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