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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Chronic Wound Treatment With Extracellular Matrix (ECM) Scaffold Made From Fish Proteins

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)

Detailed Summary:
Sponsor: Kerecis Ltd.

Current Primary Outcome: Wound healing [ Time Frame: one year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Wound granulation [ Time Frame: one year ]

Original Secondary Outcome: Same as current

Information By: Kerecis Ltd.

Dates:
Date Received: May 4, 2011
Date Started: November 2010
Date Completion:
Last Updated: February 28, 2017
Last Verified: May 2011