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

Kerecis

Status: Completed

Conditions: Punch Biopsy Wounds; Healing Times

Treatments: Device: Punch biopsies treated with MariGen Wound ECM dressing; Device: Punch biopsies treated with Oasis ECM dressing

Study type: Interventional

Funder types: Industry

Identifiers

NCT01917591

KS-0070

Details and patient eligibility

About

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

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 2 patient groups

MariGen Wound

Active Comparator group

Description:

Fish derived extra cellular matrix

Treatment:

Device: Punch biopsies treated with MariGen Wound ECM dressing

Oasis Sheet

Active Comparator group

Description:

Pig intestine derived extra cellular matrix

Treatment:

Device: Punch biopsies treated with Oasis ECM dressing