NCT01348581CompletedNot Applicable
Chronic Wound Treatment With Extracellular Matrix (ECM) Scaffold Made From Fish Proteins
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kerecis Ltd.
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Wound healing
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Marigen Wound Dressing
Experimental
Intervention: Marigen Wound Dressing (Device)
Outcomes
Primary Outcomes
Wound healing
Time Frame: one year
Secondary Outcomes
- Wound granulation(one year)
Investigators
Study Sites (1)
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