Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing
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)
Full Title of Study: “Chronic Wound Treatment With Extracellular Matrix (ECM) Scaffold Made From Fish Proteins”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 2012
Interventions
- Device: Marigen Wound Dressing
- 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.
Arms, Groups and Cohorts
- Experimental: Marigen Wound Dressing
Clinical Trial Outcome Measures
Primary Measures
- Wound healing
- Time Frame: one year
Secondary Measures
- Wound granulation
- Time Frame: one year
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Kerecis Ltd.
- Provider of Information About this Clinical Study
- Sponsor
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