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

Kerecis

Status: Completed

Conditions: Chronic Ulcer of Foot; Venous Ulcers; Diabetic Ulcers; Trauma-related Wound; Pressure Ulcers

Treatments: Device: Marigen Wound Dressing

Study type: Interventional

Funder types: Industry

Identifiers

NCT01348581

MW-ECM

KERECIS-10-106-S1

Details and patient eligibility

About

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)

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Marigen Wound Dressing

Experimental group

Treatment:

Device: Marigen Wound Dressing