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

March 6, 2024 updated by: Kerecis Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iceland
      • Reykjavik, Iceland, 105
        • Læknastofur Skipholti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MariGen Wound
Fish derived extra cellular matrix
Device: Punch biopsies treated with MariGen Wound ECM dressing
Weekly dressing changes and review of wounds.
Other Names:
  • MariGen Wound ECM wound dressings.
Active Comparator: Oasis Sheet
Pig intestine derived extra cellular matrix
Device: Punch biopsies treated with Oasis ECM dressing
Weekly dressing changes and wound review
Other Names:
  • Oasis ECM wound dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wound healing
Time Frame: 28 days
Time to epithelialisation
28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kerecis Ltd.

Investigators

  • Principal Investigator: Hugrun Thorsteinsdottir, MD Derm, The National University Hospital of Iceland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria

August 5, 2013

First Posted (Estimated)

August 6, 2013

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS-0070

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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