Healing of Punch Graft Wounds. Comparative Study Between... | NCT01917591

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

NCT01917591

Sponsor

Kerecis Ltd.

Status

Completed

Last Update Posted

Mar 8, 2024Actual

Enrollment

81Actual

Phase

Not Applicable

Conditions

Punch Biopsy Wounds
Healing Times

Interventions

Punch biopsies treated with MariGen Wound ECM dressing
Punch biopsies treated with Oasis ECM dressing

Countries

Iceland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jun 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jul 29, 2013

First Submission Date that Met QC Criteria

Aug 5, 2013

First Posted Date

Aug 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2024

Last Update Posted Date

Mar 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Conditions Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

81Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Punch biopsies treated with MariGen Wound ECM dressing	Device	Weekly dressing changes and review of wounds.	MariGen Wound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
wound healing	Time to epithelialisation	28 days

Secondary Outcomes

Measure	Description	Time Frame
Autoimmune investigations	Measurement of auto-antibodies including anti-collagen I and II antibodies	28 days
Incidence of erythema	Number of patients

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hugrun Thorsteinsdottir, MD Derm	The National University Hospital of Iceland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Læknastofur Skipholti		Reykjavik		105	Iceland

Condition Browse Module

MeSH Terms

ID	Term
D002908	Chronic Disease
D007871	Leg Ulcer
D017695	Soft Tissue Injuries
D014647	Varicose Ulcer
D014947	Wounds and Injuries
D001327	Autoimmune Diseases

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012883	Skin Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided