Establishing data for CE marking followed by clinical efficiency trail and production optimization.

Offentlig prosjektsammendrag

The use of often poorly effective wound dressings due to the cost considerations and the resulting often prolonged healing time constitute a large burden on health service providers in addition to patient pain, morbidity and dependency. Our key clinical input was to develop a wound care dressing as effective as existing collagen product for enhancement of wound healing BUT at a significantly lower price. This was achieved by substituting collagen with an inexpensive biomaterial from a nonbovine animal source. Our unique and novel product DermaRep™ has successfully completed its first clinical trial and is now applying for CE marking. The goal of this follow-on project DERMAREP is to optimize and scale up manufacture to reduce costs and show treatment cost effectiveness in a large statistically based clinical trial.