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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kerecis Ltd.
ClinicalTrials.gov Identifier:
NCT01917591
First received: July 29, 2013
Last updated: February 28, 2017
Last verified: February 2017
  Purpose
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 Intervention
Punch Biopsy Wounds Healing Times Device: Punch biopsies treated with MariGen Wound ECM dressing Device: Punch biopsies treated with Oasis ECM dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Healing of Punch Graft Wounds With Two Biologic Exracellular Matrices; a Non-inferiority Study

Resource links provided by NLM:


Further study details as provided by Kerecis Ltd.:

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


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

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

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

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


Enrollment: 81
Study Start Date: January 2013
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 29, 2013
Last Updated: February 28, 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

ClinicalTrials.gov processed this record on June 23, 2017