SP4.01 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)

Aims To evaluate the effectiveness of negative pressure wound therapy (NPWT) compared with usual care (no NPWT) for improving time to healing of surgical wounds healing by secondary intention (SWHSI). Methods A pragmatic, two arm, parallel group, unblinded randomised controlled superiority trial, which planned to randomise 696 UK patients (1:1) with a SWHSI to receive NPWT or usual care (no NPWT). Primary outcome was time to wound healing (days since randomisation). Secondary outcomes included wound infection, additional treatments, death, wound pain, health-related quality of life (HRQoL) and resource use. Results 686 participants were randomised and analysed (NPWT n=349; usual care n=337). Most SWHSI were foot or leg wounds (n=620, 90.4%) following vascular surgery (n=619, 90·2%). There was no clear evidence that NPWT reduced time to wound healing compared to usual care (HR 1·08, 95%CI 0·88 to 1·32, p=0.47). There were no statistically significant differences between groups in the odds of wound infection, antibiotic use, readmission, reoperation, amputation or death or in HRQoL or wound pain scores at any time point. Serious adverse events were rare (9 NPWT; 4 usual care). Adjusted mean incremental costs suggest that NPWT increased costs by £251.44 (95%CI: £-2,192.63 to £2,695.52), although this was not statistically significant. At NICE thresholds of £20,000 and £30,0000 / QALY gained, the probability of NPWT being cost-effective was 47.2% and 49.7% respectively. Conclusion The use of NPWT in the management of SWHSI in this patient population cannot be supported based on clinical and cost-effectiveness analysis.