Background Surgical wounds healing by secondary intention (SWHSI) occur if a surgical wound is not closed or dehisces following primary closure. SWHSI are common and adversely affect patients’ quality of life. Treatment is often prolonged, complex, and expensive. Negative Pressure Wound Therapy (NPWT) applies a controlled vacuum to the wound and is increasingly used to promote SWHSI healing despite limited rigorous evidence for the clinical and cost-effectiveness of NPWT to augment SWHSI healing. Objective Assess the clinical and cost-effectiveness of NPWT versus usual care (no NPWT) in treating SWHSI. Design and methods A pragmatic, two arm, parallel group, randomised controlled superiority trial. Twenty-eight UK NHS Trusts randomised adult patients with a SWHSI to receive NPWT or usual care (no NPWT). The planned sample size was 696 participants. Participants were followed up for 12 months via weekly telephone contact to collect the primary outcome (time to healing: full cover with no scab in days since randomisation) and clinical secondary outcomes: wound healing, surgical site infection (SSI), pain, hospital readmission, current treatment and reasons for treatment change (if applicable), reoperation, amputation, antibiotic use, death. Patient reported outcomes (pain, health-related quality of life and resource use) were collected by postal questionnaire at 3, 6 and 12 months. Validation of the Bluebelle Wound Healing Questionnaire (WHQ), a patient reported measure of SSI, was also undertaken. A cost-effectiveness decision model considering all available evidence, and a within-trial cost-utility analysis, were also undertaken to evaluate the cost-effectiveness of NPWT against usual care. Neither participants nor the investigators were blind to treatment allocation. Results Between 15.05.2019 and 13.01.2023, 686 participants were recruited, randomised and included in the analysis (NPWT n=349; usual care n=337). Most participants had a single SWHSI (n=622, 90·7%), located on the foot (n=551, 80.3%) or leg (n=69, 10.1%) arising following vascular surgery (n=619, 90·2%). Most participants had comorbidities; diabetes (n=549, 80.0%), cardiovascular disease (n=446, 65.0%) and/or peripheral vascular disease (n=349, 50.9%). Median time to healing was 187 days (NPWT) versus 195 days (usual care), with no evidence that NPWT reduced the time to wound healing compared to usual care (HR 1·08, 95%CI 0·88 to 1·32, p=0.47). Odds of readmission, reoperation, SSI, and antibiotic use were slightly higher, and odds of amputation or death slightly lower for NPWT participants. These results were not clinically or statistically significant. Bluebelle WHQ, quality of life and wound pain scores were not statistically significantly different at any timepoint. Serious adverse events were rare (9 NPWT vs 5 usual care participants). Both cost effectiveness analyses concluded that NPWT generates higher costs and marginally higher QALYs than usual care, although findings were statistically insignificant. The probability of NPWT being cost-effective was under the recommended NICE cost-effectiveness thresholds. The Bluebelle WHQ was acceptable to participants, had low levels of missing data and demonstrated good levels of sensitivity and specificity in the detection of SSI in SWHSI. Limitations The trial included a high proportion of diabetic participants with foot wounds, which may affect study generalisability. NPWT use for “wound management”, common in certain surgical specialties, was not assessed in SWHSI-2. Conclusions NPWT is not clinically or cost-effective in to augmenting healing in patients with SWHSI, particularly those with comorbidities. Future work Evaluation of methods to treat or prevent SWHSI infection and evaluation of NPWT for “wound management” are recommended. Study Registration: The trial was prospectively registered as ISRCTN 26277546 Funding details: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in the Health Technology Assessment Journal. See the NIHR Journals Library website for further project information.
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)