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Completed

NCT Number: NCT01917591

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

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

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Key information

Conditions

Punch Biopsy Wounds Autoimmune Diseases Cardiovascular Diseases Chronic Disease Disease Attributes Healing Times Immune System Diseases Leg Ulcer Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Soft Tissue Injuries Varicose Ulcer Varicose Veins Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Læknastofur Skipholti

Reykjavik, 105, Iceland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Punch biopsies treated with MariGen Wound ECM dressing

Device

Weekly dressing changes and review of wounds.

Other names: MariGen Wound ECM wound dressings.

Punch biopsies treated with Oasis ECM dressing

Device

Weekly dressing changes and wound review

Other names: Oasis ECM wound dressing

Primary outcomes

  1. wound healing

    Time frame: 28 days

    Time to epithelialisation

Secondary outcomes

  1. Autoimmune investigations

    Time frame: 28 days

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

  2. Incidence of erythema

    Time frame: 28 days

    Number of patients

  3. Pain at wound site

    Time frame: 28 days

    number of patients with significant pain at wound site

  4. Infection

    Time frame: 28 days

    Number of patients with infections

Sponsors and collaborators

Lead sponsor

Kerecis Ltd.

Industry

Registry information

Official study title

Healing of Punch Graft Wounds With Two Biologic Exracellular Matrices; a Non-inferiority Study

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 6, 2013
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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