Healing of Punch Graft Wounds. Comparative Study Between MariGen and Oasis: a Non-inferiority Study
- Conditions
- Healing TimesPunch Biopsy Wounds
- Registration Number
- NCT01917591
- Lead Sponsor
- Kerecis Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- >18 yrs
- Healthy individual
- Signature of informed consent
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method wound healing 28 days Time to epithelialisation
- Secondary Outcome Measures
Name Time Method Pain at wound site 28 days number of patients with significant pain at wound site
Infection 28 days Number of patients with infections
Autoimmune investigations 28 days Measurement of auto-antibodies including anti-collagen I and II antibodies
Incidence of erythema 28 days Number of patients
Related Research Topics
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Trial Locations
- Locations (1)
Læknastofur Skipholti
🇮🇸Reykjavik, Iceland
Læknastofur Skipholti🇮🇸Reykjavik, Iceland