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

NCT ID: NCT01348581

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-01-01

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)

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Marigen Wound Dressing

Group Type: EXPERIMENTAL

Marigen Wound Dressing

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kerecis Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National University Hospital

Reykjavik, , Iceland

Countries

Iceland

Other Identifiers

MW-ECM

Identifier Type: -

Identifier Source: secondary_id

KERECIS-10-106-S1

Identifier Type: -

Identifier Source: org_study_id