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

NCT ID: NCT01917591

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-07-31

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

Detailed Description

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Conditions

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Punch Biopsy Wounds Healing Times

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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MariGen Wound

Fish derived extra cellular matrix

Group Type ACTIVE_COMPARATOR

Punch biopsies treated with MariGen Wound ECM dressing

Intervention Type DEVICE

Weekly dressing changes and review of wounds.

Oasis Sheet

Pig intestine derived extra cellular matrix

Group Type ACTIVE_COMPARATOR

Punch biopsies treated with Oasis ECM dressing

Intervention Type DEVICE

Weekly dressing changes and wound review

Interventions

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Punch biopsies treated with MariGen Wound ECM dressing

Weekly dressing changes and review of wounds.

Intervention Type DEVICE

Punch biopsies treated with Oasis ECM dressing

Weekly dressing changes and wound review

Intervention Type DEVICE

Other Intervention Names

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MariGen Wound ECM wound dressings. Oasis ECM wound dressing

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kerecis Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hugrun Thorsteinsdottir, MD Derm

Role: PRINCIPAL_INVESTIGATOR

The National University Hospital of Iceland

Locations

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Læknastofur Skipholti

Reykjavik, , Iceland

Site Status

Countries

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Iceland

Other Identifiers

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KS-0070

Identifier Type: -

Identifier Source: org_study_id

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