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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01917591

Enrollment

Registered

2013-08-06

Start date

2013-01-31

Completion date

2013-07-31

Last updated

2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healing Times, Punch Biopsy Wounds

Keywords

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

Brief 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

Interventions

DEVICEPunch biopsies treated with MariGen Wound ECM dressing

Weekly dressing changes and review of wounds.

DEVICEPunch biopsies treated with Oasis ECM dressing

Weekly dressing changes and wound review

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
wound healing	28 days	Time to epithelialisation

Secondary

Measure	Time frame	Description
Infection	28 days	Number of patients with infections
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

Countries

Iceland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026