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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 March 2024 |
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Main ID: |
NCT01917591 |
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Date of registration:
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29/07/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Healing of Punch Graft Wounds. Comparative Study Between MariGen and Oasis: a Non-inferiority Study
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Scientific title:
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Healing of Punch Graft Wounds With Two Biologic Exracellular Matrices; a Non-inferiority Study |
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Date of first enrolment:
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January 2013 |
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Target sample size:
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81 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT01917591 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Iceland
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Contacts
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Name:
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Hugrun Thorsteinsdottir, MD Derm |
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Address:
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Telephone:
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Email:
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Affiliation:
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The National University Hospital of Iceland |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Healing Times
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Punch Biopsy Wounds
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Intervention(s)
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Device: Punch biopsies treated with Oasis ECM dressing
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Device: Punch biopsies treated with MariGen Wound ECM dressing
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Primary Outcome(s)
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wound healing
[Time Frame: 28 days]
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Secondary Outcome(s)
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Autoimmune investigations
[Time Frame: 28 days]
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Pain at wound site
[Time Frame: 28 days]
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Incidence of erythema
[Time Frame: 28 days]
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Infection
[Time Frame: 28 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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