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Clinical Trials/NCT01917591
NCT01917591CompletedNot Applicable

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

Kerecis Ltd.2 sites in 1 country81 target enrollmentStarted: January 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
81
Locations
2
Primary Endpoint
wound healing
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Outcomes

Primary Outcomes

wound healing

Time Frame: 28 days

Time to epithelialisation

Secondary Outcomes

  • Pain at wound site(28 days)
  • Infection(28 days)
  • Autoimmune investigations(28 days)
  • Incidence of erythema(28 days)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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