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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01348581
Other study ID # KERECIS-10-106-S1
Secondary ID MW-ECM
Status Completed
Phase N/A
First received May 4, 2011
Last updated February 28, 2017
Start date November 2010
Est. completion date January 1, 2013

Study information

Verified date May 2011
Source Kerecis Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date January 1, 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
Iceland National University Hospital Reykjavik

Sponsors (1)

Lead Sponsor Collaborator
Kerecis Ltd.

Country where clinical trial is conducted

Iceland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wound healing one year
Secondary Wound granulation one year
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