An Acellular Epithelial Skin Substitute in Deep Partial-thickness Burns

Wound Healing Clinical Trial

Official title:

A Prospective Noninferiority Trial to Compare an Acellular Epithelial Skin Substitute With Autologous Split-thickness Skin Grafts in Deep Partial-thickness Burns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454310
• Other study ID #: SUPRA-VS-STSG-2010
• Status: Completed
• Phase: Phase 4
• First received: October 15, 2011
• Last updated: October 18, 2011
• Start date: November 2010
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scar Formation
• Wound Healing

Intervention

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
• Autologous skin
Matched burn wound is covered by autologous skin after tangential excision.

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Burn Center, Department of Plastic and Reconstructive Surgery	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (in days +/- standarddeviation) to complete re-epithelialisation in acellular skin substitue area versus autologous skin	Time to complete re-epithelialisation measured in days after surgery	1 year	Yes
Secondary	Skin quality- ratio acellular skin substitute/healthy skin versus ratio autologous skin/healthy skin	Quality of the skin is measured two-fold: Subjective scar scors: Vancouver Scar Scale, Patient and Observer Scar Scale; Objective scar evaluation by a non-invasive suction device, that measures viscoelastic parameter.	1 year	Yes