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

NCT01917591 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2024-03-08

No results posted yet for this study

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

Conditions

  • Punch Biopsy Wounds
  • Healing Times

Interventions

DEVICE

Punch biopsies treated with MariGen Wound ECM dressing

Weekly dressing changes and review of wounds.

DEVICE

Punch biopsies treated with Oasis ECM dressing

Weekly dressing changes and wound review

Sponsors & Collaborators

  • Kerecis Ltd.

    lead INDUSTRY

Principal Investigators

  • Hugrun Thorsteinsdottir, MD Derm · The National University Hospital of Iceland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-06-30
Completion
2013-07-31

Countries

  • Iceland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01917591 on ClinicalTrials.gov