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

NCT01917591 — Not applicable, Completed, 81 participants, Kerecis Ltd.

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

Registry	NCT01917591
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	81 (Actual)
Sponsor	Kerecis Ltd. (Industry)
Conditions	Punch Biopsy Wounds, Healing Times
Interventions	Punch biopsies treated with MariGen Wound ECM dressing, Punch biopsies treated with Oasis ECM dressing (Device)
Dates	start 2013-01-01, primary completion 2013-06-01, completion 2013-07-01, first posted 2013-08-06, last updated 2024-03-08
Locations	1 site in Iceland

-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

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+Arms and interventions

Arm	Type	Interventions	Description
MariGen Wound	Active comparator	Device: Punch biopsies treated with MariGen Wound ECM dressing	Fish derived extra cellular matrix
Oasis Sheet	Active comparator	Device: Punch biopsies treated with Oasis ECM dressing	Pig intestine derived extra cellular matrix

Punch biopsies treated with MariGen Wound ECM dressing (Device), also known as MariGen Wound ECM wound dressings.: Weekly dressing changes and review of wounds.
Punch biopsies treated with Oasis ECM dressing (Device), also known as Oasis ECM wound dressing: Weekly dressing changes and wound review

+Outcome measures

Primary outcomes

wound healing [28 days]: Time to epithelialisation

Secondary outcomes

Autoimmune investigations [28 days]: Measurement of auto-antibodies including anti-collagen I and II antibodies
Incidence of erythema [28 days]: Number of patients
Pain at wound site [28 days]: number of patients with significant pain at wound site
Infection [28 days]: Number of patients with infections

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Læknastofur Skipholti	Reykjavik	Iceland

+Investigators

Hugrun Thorsteinsdottir, MD Derm, Principal investigator, The National University Hospital of Iceland