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

NCT01348581 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2017-03-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Kerecis Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-12-31
Completion
2013-01-01

Countries

  • Iceland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01348581 on ClinicalTrials.gov