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

Not Applicable

Completed

• Conditions: Healing Times; Punch Biopsy Wounds
• Interventions: Device: Punch biopsies treated with MariGen Wound ECM dressing; Device: Punch biopsies treated with Oasis ECM dressing

• 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

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-06
• Study Completion: 2013-07
• Study First Submitted: 2013-07-29
• Study First Submitted QC: 2013-08-05
• Study First Posted: 2013-08-06
• Status Verified: 2017-02
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MariGen Wound	Punch biopsies treated with MariGen Wound ECM dressing	Fish derived extra cellular matrix
Oasis Sheet	Punch biopsies treated with Oasis ECM dressing	Pig intestine derived extra cellular matrix

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

Trial Locations

Locations (1)

Læknastofur Skipholti; 🇮🇸 Reykjavik, Iceland