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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

October 15, 2011
October 18, 2011
November 2010
July 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01454310 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
An Acellular Epithelial Skin Substitute in Deep Partial-thickness Burns
A Prospective Noninferiority Trial to Compare an Acellular Epithelial Skin Substitute With Autologous Split-thickness Skin Grafts in Deep Partial-thickness Burns

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Wound Healing
  • Scar Formation
  • 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
  • Device: Autologous skin
    Matched burn wound is covered by autologous skin after tangential excision.
  • Experimental: Acellular skin substitute
    Intervention: Device: Wound coverage by acellular skin substitute
  • Active Comparator: Autologous skin graft
    Intervention: Device: Autologous skin
Uhlig C, Rapp M, Hartmann B, Hierlemann H, Planck H, Dittel KK. Suprathel-an innovative, resorbable skin substitute for the treatment of burn victims. Burns. 2007 Mar;33(2):221-9. Epub 2006 Nov 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
September 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01454310
SUPRA-VS-STSG-2010
No
Harald Franz Selig, Medical University of Vienna
Medical University of Vienna
Not Provided
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
Medical University of Vienna
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP