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An Acellular Epithelial Skin Substitute in Deep Partial-thickness Burns

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ClinicalTrials.gov Identifier: NCT01454310
Recruitment Status : Completed
First Posted : October 19, 2011
Last Update Posted : October 19, 2011
Sponsor:
Information provided by (Responsible Party):
Harald Franz Selig, Medical University of Vienna

Brief Summary:
The purpose of the study is to compare an acellular epithelial skin substitute with autologous split-thickness skin grafts (STSGs) in deep partial-thickness burns. The objective is to evaluate skin quality and scar formation by using subjective and objective burn scar assessments in order to present valuable data for another additional option of wound coverage in deep partial-thickness burns. The investigators hypothesized that the acellular epithelial skin substitute is at least not inferior to autologous skin grafts.

Condition or disease Intervention/treatment Phase
Wound Healing Scar Formation Device: Wound coverage by acellular skin substitute Device: Autologous skin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Noninferiority Trial to Compare an Acellular Epithelial Skin Substitute With Autologous Split-thickness Skin Grafts in Deep Partial-thickness Burns
Study Start Date : November 2010
Primary Completion Date : July 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Acellular skin substitute Device: Wound coverage by acellular skin substitute
Burn wounds are covered by an acellular skin substitute and remains 10-14 days that peals away in line with re-epithelialisation
Other Name: Suprathel
Active Comparator: Autologous skin graft Device: Autologous skin
Matched burn wound is covered by autologous skin after tangential excision.



Primary Outcome Measures :
  1. Time (in days +/- standarddeviation) to complete re-epithelialisation in acellular skin substitue area versus autologous skin [ Time Frame: 1 year ]
    Time to complete re-epithelialisation measured in days after surgery


Secondary Outcome Measures :
  1. Skin quality- ratio acellular skin substitute/healthy skin versus ratio autologous skin/healthy skin [ Time Frame: 1 year ]

    Quality of the skin is measured two-fold:

    1. Subjective scar scors: Vancouver Scar Scale, Patient and Observer Scar Scale
    2. Objective scar evaluation by a non-invasive suction device, that measures viscoelastic parameter.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 18 years of age
  • verified deep partial-thickness burns
  • early tangential excision of burn wound (3-5 days after trauma)

Exclusion Criteria:

  • Pregnancy
  • ABSI-Score >13
  • Active tumor or immune-mediated disease
  • Patient refusal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454310


Locations
Austria
Medical University of Vienna, Burn Center, Department of Plastic and Reconstructive Surgery
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Study Chair: Lars P Kamolz, MD, PhD, MSc Medical University of Vienna
Principal Investigator: Maike Keck, MD Medical University of Vienna, Department of Plastic and Reconstructive Surgery

Publications:
Responsible Party: Harald Franz Selig, MD, research assistant, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01454310     History of Changes
Other Study ID Numbers: SUPRA-VS-STSG-2010
First Posted: October 19, 2011    Key Record Dates
Last Update Posted: October 19, 2011
Last Verified: October 2011

Keywords provided by Harald Franz Selig, Medical University of Vienna:
Skin substitutes
Split-thickness skin graft
Burn wound
Scar formation
Skin quality