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

NCT01917591 | Completed DMC

• 1 other identifier: KS-0070
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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

Conditions

Punch Biopsy Wounds; Healing Times

Keywords

Bandages; Biological Dressings; Chronic Disease; Collagen; Epithelium; Extracellular Matrix; Extra Cellular Matrix; Fibroblasts; Granulation Tissue; Leg Ulcer; Middle Aged; Prospective Studies; Soft Tissue Injuries; Treatment Outcome; Varicose Ulcer; Wound Healing; Wounds and Injuries; biopsy; autoimmunity

Outcome Measures

Primary Outcomes (1)

• wound healing

  Time to epithelialisation

  28 days

Secondary Outcomes (4)

• Autoimmune investigations

  28 days

• Incidence of erythema

  28 days

• Pain at wound site

  28 days

• Infection

  28 days

Study Arms (2)

MariGen Wound

ACTIVE COMPARATOR

Fish derived extra cellular matrix

Device: Punch biopsies treated with MariGen Wound ECM dressing

Oasis Sheet

ACTIVE COMPARATOR

Pig intestine derived extra cellular matrix

Device: Punch biopsies treated with Oasis ECM dressing

Interventions

Punch biopsies treated with MariGen Wound ECM dressing DEVICE

Weekly dressing changes and review of wounds.

Also known as: MariGen Wound ECM wound dressings.

MariGen Wound

Punch biopsies treated with Oasis ECM dressing DEVICE

Weekly dressing changes and wound review

Also known as: Oasis ECM wound dressing

Oasis Sheet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 yrs
• Healthy individual
• Signature of informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kerecis Ltd.: lead

Study Sites (1)

Læknastofur Skipholti

Reykjavik, 105, Iceland

Location

MeSH Terms

Conditions

Chronic Disease; Leg Ulcer; Soft Tissue Injuries; Varicose Ulcer; Wounds and Injuries; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Immune System Diseases

Study Officials

• Hugrun Thorsteinsdottir, MD Derm

  The National University Hospital of Iceland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: August 6, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 8, 2024

Record last verified: 2017-02

Locations

IC (1)