Punch Biopsy WoundsNCT01917591
Healing of Punch Graft Wounds. Comparative Study Between MariGen and Oasis: a Non-inferiority Study
A study testing Punch biopsies treated with MariGen Wound ECM dressing and Punch biopsies treated with Oasis ECM dressing in people with Punch Biopsy Wounds and Healing Times, run by Kerecis Ltd. at 1 site in Iceland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Punch Biopsy Wounds, Healing Times
- What is being tested?
- Punch biopsies treated with MariGen Wound ECM dressing and Punch biopsies treated with Oasis ECM dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteIceland
- Study dates
- Jan 2013to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 yrs
- Healthy individual
- Signature of informed consent
Who cannot join
- Autoimmune disease
- Immunosuppressive treatment
- Use of addictive drugs
- Excessive use of alcohol
- Known fish allergy
- Known allergy to proteins with porcine origin
Show all 9Show fewer
- Peripheral vascular disease
- Pregnant women
- Persons receiving anticoagulation therapy or systemic corticosteroids will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healing of Punch Graft Wounds With Two Biologic Exracellular Matrices; 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
- Conditions
- Punch Biopsy Wounds, Healing Times
- Being tested
- Punch biopsies treated with MariGen Wound ECM dressing, Punch biopsies treated with Oasis ECM dressing
- 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
- Medical subject headings
- Chronic Disease, Leg Ulcer, Soft Tissue Injuries, Varicose Ulcer, Wounds and Injuries, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Punch biopsies treated with MariGen Wound ECM dressingDevice
Also called MariGen Wound ECM wound dressings.
Weekly dressing changes and review of wounds.
Punch biopsies treated with Oasis ECM dressingDevice
Also called Oasis ECM wound dressing
Weekly dressing changes and wound review
| Study group | Role | What they receive |
|---|---|---|
| MariGen Wound | Active comparator | Fish derived extra cellular matrix Receives: Device: Punch biopsies treated with MariGen Wound ECM dressing |
| Oasis Sheet | Active comparator | Pig intestine derived extra cellular matrix Receives: Device: Punch biopsies treated with Oasis ECM dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing
Time to epithelialisation
Measured: 28 days
Secondary outcomes (4)
Autoimmune investigations
Measurement of auto-antibodies including anti-collagen I and II antibodies
Measured: 28 days
Incidence of erythema
Number of patients
Measured: 28 days
Pain at wound site
number of patients with significant pain at wound site
Measured: 28 days
Infection
Number of patients with infections
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Punch Biopsy WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kerecis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hugrun Thorsteinsdottir, MD Derm, Principal investigator, The National University Hospital of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917591
- Sponsor's protocol ID
- KS-0070
- Status last verified
- Feb 2017
- First submitted
- 29 Jul 2013
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing of Punch Graft Wounds With Two Biologic Exracellular Matrices; a Non-inferiority Study
- ClinicalTrials.gov ID
- NCT01917591
- Acronym / sponsor ID
- KS-0070
- Conditions
- Punch Biopsy Wounds, Healing Times
- Keywords
- Bandages, Biological Dressings, Chronic Disease, Collagen, Epithelium, Extracellular Matrix, Extra Cellular Matrix, Fibroblasts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Kerecis Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MariGen Wound | Active comparator | Device: Punch biopsies treated with MariGen Wound ECM dressingFish derived extra cellular matrix |
| Oasis Sheet | Active comparator | Device: Punch biopsies treated with Oasis ECM dressingPig intestine derived extra cellular matrix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 yrs
- Healthy individual
- Signature of informed consent
Key exclusion criteria (9 listed)
- Autoimmune disease
- Immunosuppressive treatment
- Use of addictive drugs
- Excessive use of alcohol
- Known fish allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Punch biopsies treated with MariGen Wound ECM dressingAlso: MariGen Wound ECM wound dressings.Weekly dressing changes and review of wounds. | Device | MariGen Wound |
| Punch biopsies treated with Oasis ECM dressingAlso: Oasis ECM wound dressingWeekly dressing changes and wound review | Device | Oasis Sheet |
Primary outcome
wound healing
Time frame: 28 days
Time to epithelialisation
4 secondary outcomes
Autoimmune investigations
Time frame: 28 days
Incidence of erythema
Time frame: 28 days
Pain at wound site
Time frame: 28 days
Infection
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugrun Thorsteinsdottir, MD Derm principal investigator
The National University Hospital of Iceland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Punch biopsies treated with MariGen Wound ECM dressing and Punch biopsies treated with Oasis ECM dressing in people with Punch Biopsy Wounds and Healing Times, run by Kerecis Ltd. at 1 site in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound healing (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.