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

Study Overview
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Brief Summary
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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

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

Conditions
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Punch Biopsy Wounds, Healing Times

Intervention / Treatment
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* Device: Punch biopsies treated with MariGen Wound ECM dressing
* Device: Punch biopsies treated with Oasis ECM dressing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MariGen Wound<br>Fish derived extra cellular matrix | Device: Punch biopsies treated with MariGen Wound ECM dressing<br>* Weekly dressing changes and review of wounds.<br>* Other names: MariGen Wound ECM wound dressings.;|
| Active Comparator: Oasis Sheet<br>Pig intestine derived extra cellular matrix | Device: Punch biopsies treated with Oasis ECM dressing<br>* Weekly dressing changes and wound review<br>* Other names: Oasis ECM wound dressing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound healing | Time to epithelialisation | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autoimmune investigations | Measurement of auto-antibodies including anti-collagen I and II antibodies | 28 days | 
| Incidence of erythema | Number of patients | 28 days | 
| Pain | number of patients with significant pain | 28 days | 
| Infection | Number of patients with infections | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bandages, Biological Dressings, Chronic Disease, Collagen, Epithelium, Extracellular Matrix, Extra Cellular Matrix, Fibroblasts, Granulation Tissue, Leg Ulcer, Middle Aged, Prospective Studies, Soft Tissue Injuries, Treatment Outcome, Varicose Ulcer, Wound Healing, Wounds and Injuries, biopsy, autoimmunity