Back to resultsHealing of Punch Graft Wounds. Comparative Study Between MariGen and Oasis: a Non-inferiority Study
Primary Purpose
Punch Biopsy Wounds, Healing Times
Status
Completed
Phase
Not Applicable
Locations
Iceland
Study Type
Interventional
Intervention
Punch biopsies treated with MariGen Wound ECM dressing
Punch biopsies treated with Oasis ECM dressing
Sponsored by
About this trial
This is an interventional treatment trial for Punch Biopsy Wounds focused on measuring 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
Eligibility Criteria
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.
Sites / Locations
- Læknastofur Skipholti
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
MariGen Wound
Oasis Sheet
Arm Description
Fish derived extra cellular matrix
Pig intestine derived extra cellular matrix
Outcomes
Primary Outcome Measures
wound healing
Time to epithelialisation
Secondary Outcome Measures
Autoimmune investigations
Measurement of auto-antibodies including anti-collagen I and II antibodies
Incidence of erythema
Number of patients
Pain
number of patients with significant pain
Infection
Number of patients with infections
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01917591
Brief Title
Healing of Punch Graft Wounds. Comparative Study Between MariGen and Oasis: a Non-inferiority Study
Official Title
Healing of Punch Graft Wounds With Two Biologic Exracellular Matrices; a Non-inferiority Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kerecis Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MariGen Wound
Arm Type
Active Comparator
Arm Description
Fish derived extra cellular matrix
Arm Title
Oasis Sheet
Arm Type
Active Comparator
Arm Description
Pig intestine derived extra cellular matrix
Intervention Type
Device
Intervention Name(s)
Punch biopsies treated with MariGen Wound ECM dressing
Other Intervention Name(s)
MariGen Wound ECM wound dressings.
Intervention Description
Weekly dressing changes and review of wounds.
Intervention Type
Device
Intervention Name(s)
Punch biopsies treated with Oasis ECM dressing
Other Intervention Name(s)
Oasis ECM wound dressing
Intervention Description
Weekly dressing changes and wound review
Primary Outcome Measure Information:
Title
wound healing
Description
Time to epithelialisation
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Autoimmune investigations
Description
Measurement of auto-antibodies including anti-collagen I and II antibodies
Time Frame
28 days
Title
Incidence of erythema
Description
Number of patients
Time Frame
28 days
Title
Pain
Description
number of patients with significant pain
Time Frame
28 days
Title
Infection
Description
Number of patients with infections
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugrun Thorsteinsdottir, MD Derm
Organizational Affiliation
The National University Hospital of Iceland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Læknastofur Skipholti
City
Reykjavik
ZIP/Postal Code
105
Country
Iceland
12. IPD Sharing Statement
Learn more about this trial
Healing of Punch Graft Wounds. Comparative Study Between MariGen and Oasis: a Non-inferiority Study
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