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

N/ACompletedNCT01917591

Kerecis Ltd.81 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Punch Biopsy Wounds Healing Times

Interventions

Punch biopsies treated with MariGen Wound ECM dressingDEVICE

Weekly dressing changes and review of wounds.

Punch biopsies treated with Oasis ECM dressingDEVICE

Weekly dressing changes and wound review

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Læknastofur Skipholti

Reykjavik, Iceland

Outcomes

Primary Outcomes

wound healing

Time to epithelialisation

Time frame: 28 days

Secondary Outcomes

Autoimmune investigations

Measurement of auto-antibodies including anti-collagen I and II antibodies

Time frame: 28 days

Incidence of erythema

Number of patients

Time frame: 28 days

Pain at wound site

number of patients with significant pain at wound site

Time frame: 28 days

Infection

Number of patients with infections

Time frame: 28 days

Data from ClinicalTrials.gov

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