The cost-effectiveness of wound-edge protection devices compared to standard care in reducing surgical site infection after laparotomy: an economic evaluation alongside the ROSSINI trial.

BACKGROUND: Wound-edge protection devices (WEPDs) have been used in surgery for more than 40 years to reduce surgical site infection (SSI). No economic evaluation of WEPDs against any comparator has ever been conducted. The aim of the paper was to assess whether WEPDs are cost-effective in reducing SSI compared to standard care alone in the United Kingdom. METHODS AND FINDINGS: An economic evaluation was conducted alongside the ROSSINI trial. The study perspective was that of the UK National Health Service and the time horizon was 30 days post-operatively. The study was conducted in 21 UK hospitals. 760 patients undergoing laparotomy were randomised to either WEPD or standard care and 735 were included in the primary analysis. The main economic outcome was cost-effectiveness based on incremental cost (£) per quality adjusted life year (QALY) gained. Patients in the WEPD arm accessed health care worth £5,420 on average and gained 0.02131 QALYs, compared to £5,130 and 0.02133 QALYs gained in the standard care arm. The WEPD strategy was more costly and equally effective compared to standard care, but there was significant uncertainty around incremental costs and QALYs. The findings were robust to a range of sensitivity analyses. CONCLUSIONS: There is no evidence to suggest that WEPDs can be considered a cost effective device to reduce SSI. Their continued use is a waste of limited health care resources.