NCT01348581

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Kerecis Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-12-01
• Completion: 2013-01-01
• First posted: 2011-05-05
• Last updated: 2017-03-03

Locations

1 site across 1 country: Iceland