A pragmatic multicentre randomised controlled trial to assess the clinical and cost effectiveness of negative pressure wound therapy versus usual care for surgical wounds healing by secondary intention (SWHSI 2)
A large UK trial is testing whether negative pressure wound therapy—a vacuum dressing that sucks fluid from a wound—can heal surgical wounds that are left open to heal from the inside out faster than standard dressings. These "healing by secondary intention" wounds occur after infection, dehiscence, or planned open management, and they can take months to close, causing pain, infection risk, and high healthcare costs. Current practice varies widely, and there is no robust evidence on whether the expensive negative pressure devices are worth using for this specific wound type. If the therapy proves effective, it could cut healing time substantially, reduce the burden of weekly dressing changes and clinic visits, and save the NHS money by shortening treatment episodes. The trial also includes a full economic analysis to determine cost-effectiveness, so the results will directly inform NHS procurement and clinical guidelines. If the therapy shows no advantage, the trial will prevent wasteful spending on devices that offer no benefit over simple dressings. Either way, the findings will settle a long-standing uncertainty in surgical wound care.
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DESIGN: Multi-centre, cross surgical specialty, two-arm parallel group, pragmatic, randomised controlled trial, with internal pilot, to assess the clinical & cost effectiveness of negative pressure wound therapy (NPWT) versus usual care (no NPWT) as a treatment for surgical wounds healing by secondary intention (SWHSI). Randomisation will be completed by York Trials Unit’s secure web based service, ensuring adequate allocation concealment, using a 1:1 ratio stratified by wound location (foot/leg, abdomen, other). SETTING: Secondary & community NHS Trusts & primary care centres. POPULATION: Consenting adults with a SWHSI ready & appropriate for NPWT or wound dressing treatment, receiving adequate nutrition will be eligible. Patients contraindicated to NPWT, previous receipt of NPWT on the wound & wounds non-surgical in origin, will be excluded. TECHNOLOGY TO BE ASSESSED: Intervention: NPWT devices in use in the NHS. Control: Any dressing without NPWT (usual care). The clinical care team will determine NPWT device or dressing type & treatment regimen. OUTCOMES: Primary; Time to healing in days since randomisation (i.e. complete epithelial cover in the absence of a scab), verified using standardised photographs by independent blinded observers. Secondary; Clinical & adverse events, wound infection (Bluebelle WHQ (3)), pain, Quality of Life (EQ5D-5L (4)) & resource use. ASSESSMENT: Epidemiological data including comorbidities, smoking status, and surgical procedure detail (e.g. urgency and contamination level) will be collected at baseline. Randomised patients will be contacted weekly to monitor wound healing and other clinical and adverse events. Where healing is self-reported by the participant three visits on consecutive weeks will be made and photographs taken for blinded outcome verification. EQ5D-5L, wound pain, infection (Bluebelle WHQ) and resource use will be assessed at 3, 6 and 12 months by postal questionnaires. ANALYSIS: Primary analysis will assess time to healing using Kaplan Meier curves and Cox Proportional Hazards regression models with shared centre frailty effects, adjusting for baseline wound size, duration and location. CACE analysis will assess treatment effects in the presence of non-compliance. Secondary outcomes will be analysed using appropriate regression techniques. The economic analysis will assess cost effectiveness. A decision analytic model will be generated to incorporate evidence from the existing evidence base, and from the trial to establish which of the relevant treatment(s) are most cost-effective. SAMPLE SIZE: To detect a 25% reduction in median time to healing (from 86 days with standard care to 65 days with NPWT), with 90% power, and allowing for 20% attrition, the total sample size required is 696 participants (348 NPWT; 348 Usual Care). PROJECT TIMETABLE: Total project duration - 48 months - Set-up; 6 months - Internal pilot; 6 months, 10 sites recruiting 1-2 patients/month (100 participants) - Full recruitment; 18 months, 20 sites recruiting 1-2 patients/month (596 participants) - Follow up; 12 months - Data cleaning, analysis & reporting; 6 months. PROJECT TEAM: Our multidisciplinary team will build on experience in recruiting, retaining & collecting data from SWHSI patients, developed through work over the past 5 years on the NIHR PGfAR (RP-PG-0609-10171). Our project team includes surgical specialty leads, and we have developed links to the MRC ConDUCT-II Hub.
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