Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing

The clinical study is designed to assess the effectiveness, safety and non-immunogenicity of fish skin wound dressing extracellular matrix (ECM) in treating chronic wounds. The wound dressing is indicated for the management of difficult to heal and chronic wounds. The matrix is cut to fit the wound and is applied to the wound bed. An absorptive secondary dressing is put on top. Further dressing of the wound depends on the etiology. The indications for use are: partial and full-thickness wounds pressure ulcers venous ulcers diabetic ulcers chronic vascular ulcers tunneled/undermined wounds trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)

Adult, Aged, Aged, 80 and over, Bandages, Biological Dressings, Chronic Disease, Collagen, Epithelium, Extracellular Matrix, Fibroblasts, Granulation Tissue, Humans, Leg Ulcer, Middle Aged, Prospective Studies, Soft Tissue Injuries, Treatment Outcome, Varicose Ulcer, Wound Healing, Wounds and Injuries

The dressing is changed at least twice a week, with no more than five days between dressing changes. It is extremely important that the dressings are changed sufficiently often. On highly exuding ulcers the three or four dressing changes per week may be necessary. Duration is four weeks.

Inclusion Criteria: Venous leg ulcer Arterial leg ulcer Rheumatic leg ulcer Hydrostatic leg ulcer Ulcer where healing is delayed because of drug therapy Non-healing ulcer due to known or unknown causes Exclusion Criteria: Active infection