An Acellular Epithelial Skin Substitute in Deep Partial-thickness Burns

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Harald Franz Selig, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01454310
First received: October 15, 2011
Last updated: October 18, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Wound Healing
Scar Formation
Device: Wound coverage by acellular skin substitute
Device: Autologous skin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

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


Secondary Outcome Measures:
  • Skin quality- ratio acellular skin substitute/healthy skin versus ratio autologous skin/healthy skin [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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.


Enrollment: 18
Study Start Date: November 2010
Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: October 15, 2011
Last Updated: October 18, 2011
Health Authority: Austria: Ethikkommission

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

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014