Burns and Scalds

The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with the use of Debrisoft® Duo within the certified indications and under the conditions of routine use.

The design of the study is a clinical trial of Debridement Pad in subjects with superficial, chronic and acute wounds consisting of Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by secondary intention, traumatic or surgical wounds and burns and scalds. The performance data from this study will support clinically meaningful rates of successful improvement in wound bed condition immediately after treatment.