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

Kerecis Ltd.37 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pressure Ulcers Venous Ulcers Diabetic Ulcers Chronic Ulcer of Foot

Interventions

Marigen Wound DressingDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Wound healing

Time frame: one year

Secondary Outcomes

Wound granulation