Healing of Punch Graft Wounds. Comparative Study Between MariGen and Oasis: a Non-inferiority Study

Healing Times Clinical Trial

Official title:

Healing of Punch Graft Wounds With Two Biologic Exracellular Matrices; a Non-inferiority Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917591
• Other study ID #: KS-0070
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: July 2013

Study information

• Verified date: February 2017
• Source: Kerecis Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective is to determine, if healing of punch biopsy wounds treated with the fish skin derived MariGen Wound dressing is non-inferior to healing with wounds treated with pig intestines derived Oasis Sheet wound dressing. Secondary endpoints are: Incidence of erythema, Pain, Infection, Quantitative measurements of autoantibodies at baseline and 4 weeks after start of treatment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >18 yrs

• Healthy individual

• Signature of informed consent

Exclusion Criteria:

• Autoimmune disease

• Immunosuppressive treatment

• Use of addictive drugs

• Excessive use of alcohol

• Known fish allergy

• Known allergy to proteins with porcine origin

• Peripheral vascular disease

• Pregnant women

• Persons receiving anticoagulation therapy or systemic corticosteroids will be excluded.

Related Conditions & MeSH terms

• Healing Times
• Punch Biopsy Wounds
• Wounds and Injuries

Intervention

Device:
• Punch biopsies treated with MariGen Wound ECM dressing
Weekly dressing changes and review of wounds.
• Punch biopsies treated with Oasis ECM dressing
Weekly dressing changes and wound review

Locations

Country	Name	City	State
Iceland	Læknastofur Skipholti	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	Time to epithelialisation	28 days
Secondary	Autoimmune investigations	Measurement of auto-antibodies including anti-collagen I and II antibodies	28 days
Secondary	Incidence of erythema	Number of patients	28 days
Secondary	Pain at wound site	number of patients with significant pain at wound site	28 days
Secondary	Infection	Number of patients with infections	28 days