A Prospective Clinical Study to Confirm the Safety and Performance of a Canister-Based Single-Use Negative Pressure Wound Therapy System in Low-to-Moderately Exuding Chronic Wounds

Abstract

This clinical investigation was undertaken to confirm the safety and performance of a canister-based single-use negative pressure wound therapy system when used as intended in the management of low-to-moderately exuding chronic wounds, including diabetes-related foot ulcers (n = 34), venous leg ulcers (n = 34), and pressure ulcers (n = 36) for up to 28 days. Using a prospective non-comparative, multi-centre design, device performance was evaluated at 14 sites in seven European countries. The study covered a broad spectrum of wounds, reflecting the inclusion of both inpatients (67.7%) and outpatients (32.3%). The primary outcome measure was wound progress. Overall, wounds were deemed improved since the previous clinic visit in 76.3% of visits and reductions in both absolute and relative wound size were noted over the study period. The device was considered effective and easy to apply by investigators, with no unexpected safety concerns noted.