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Randomized Controlled Trial
. 2025 May 10;405(10490):1689-1699.
doi: 10.1016/S0140-6736(25)00143-6. Epub 2025 Apr 15.

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

Catherine Arundel  1 , Laura Mandefield  2 , Caroline Fairhurst  2 , Kalpita Baird  2 , Athanasios Gkekas  2 , Pedro Saramago  3 , Ian Chetter  4 ; SWHSI-2 Trial Investigators
Collaborators, Affiliations
Randomized Controlled Trial

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

Catherine Arundel et al. Lancet. .

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.

Funding: National Institute for Health Research Health Technology Assessment Programme.

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Conflict of interest statement

Declaration of interests Aside from research funding received for other projects outside of this work, CA reports financial support for attendance to present the study at the Vascular Society of Great Britain and Ireland Annual Scientific Meetings and LM reports participation as an independent member of Data Monitoring and Ethics committees for unrelated studies (REACH-ASD and ACORN II). All other authors declare no competing interests.

Figures

Figure 1
Figure 1
Trial profile NPWT=negative pressure wound therapy. SWHSI=surgical wound healing by secondary intention. *There were six system randomisation errors where the same participant was randomised multiple times. These were removed from any analysis, leaving 686 participants.
Figure 2
Figure 2
Kaplan–Meier curve of time from randomisation to healing in SWHSI patients receiving NPWT or usual care treatments HR=hazard ratio. NPWT=negative pressure wound therapy. SWHSI=surgical wound healing by secondary intention.
See this image and copyright information in PMC

Comment in

References

    1. Chetter IC, Oswald AV, Fletcher M, Dumville JC, Cullum NA. A survey of patients with surgical wounds healing by secondary intention; an assessment of prevalence, aetiology, duration and management. J Tissue Viability. 2017;26:103–107. - PMC - PubMed
    1. Chetter IC, Oswald AV, McGinnis E, et al. Patients with surgical wounds healing by secondary intention: a prospective, cohort study. Int J Nurs Stud. 2019;89:62–71. - PubMed
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    1. Saramago-Goncalves PR, Claxton K, Welton N, Soares M. Bayesian econometric modelling of observational data for cost-effectiveness analysis: establishing the value of negative pressure wound therapy in the healing of open surgical wounds. J R Stat Soc Ser A Stat Soc. 2020;183:1575–1593.

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