Healing of Punch Graft Wounds. Comparative Study Between MariGen & Oasis:

Clinical Trial 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

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

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Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
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NCT number	NCT01917591
Study type	Interventional
Source	Kerecis Ltd.
Contact
Status	Completed
Phase	N/A
Start date	January 2013
Completion date	July 2013

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms