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

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ClinicalTrials.gov Identifier: NCT01917591
Recruitment Status : Completed
First Posted : August 6, 2013
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
Punch Biopsy Wounds Healing Times Device: Punch biopsies treated with MariGen Wound ECM dressing Device: Punch biopsies treated with Oasis ECM dressing

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Healing of Punch Graft Wounds With Two Biologic Exracellular Matrices; a Non-inferiority Study
Study Start Date : January 2013
Primary Completion Date : June 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: Oasis ECM wound dressing


Outcome Measures

Primary Outcome Measures :
  1. wound healing [ Time Frame: 28 days ]
    Time to epithelialisation


Secondary Outcome Measures :
  1. Autoimmune investigations [ Time Frame: 28 days ]
    Measurement of auto-antibodies including anti-collagen I and II antibodies

  2. Incidence of erythema [ Time Frame: 28 days ]
    Number of patients

  3. Pain [ Time Frame: 28 days ]
    number of patients with significant pain

  4. Infection [ Time Frame: 28 days ]
    Number of patients with infections


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917591


Locations
Iceland
Læknastofur Skipholti
Reykjavik, Iceland, 105
Sponsors and Collaborators
Kerecis Ltd.
Investigators
Principal Investigator: Hugrun Thorsteinsdottir, MD Derm The National University Hospital of Iceland
More Information

Responsible Party: Kerecis Ltd.
ClinicalTrials.gov Identifier: NCT01917591     History of Changes
Other Study ID Numbers: KS-0070
First Posted: August 6, 2013    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017

Keywords provided by Kerecis Ltd.:
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

Additional relevant MeSH terms:
Wounds and Injuries