Multicenter, Randomized, Non-inferiority Study Comparing Debrisoft Duo and Debrisoft Pad for Wound Debridement

What this Trial Is About

Researchers are evaluating the performance and safety of Debrisoft Duo compared to Debrisoft Pad for wound debridement. This study aims to confirm how well Debrisoft Duo works and to collect data on expected and unexpected adverse events when used as intended during routine care. The trial is designed as a multicenter, randomized, non-inferiority controlled clinical investigation involving patients with various wounds such as diabetic ulcers, arterial ulcers, pressure ulcers, burns, and surgical wounds. Participants will be randomly assigned to receive wound debridement with either the investigational Debrisoft Duo, a two-sided pad featuring a unique textured side to loosen adherent wound debris, or the comparator Debrisoft Pad, a one-sided pad without the textured side. Treatment occurs during a single study visit where clinical examinations and wound photographs will be taken to assess the debridement. During the visit, researchers will evaluate the reduction of fibrinous and necrotic tissue using standardized measures and investigator assessments. They will also monitor device-related adverse events, wound bed condition changes, pain levels, debridement time, product usage, and both patient and user satisfaction. The study focuses on safety and performance outcomes measured within one day after treatment, with participation limited to adult patients aged 18 and older.

Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds