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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 15, 2011

Last Updated Date

October 18, 2011

Start Date ^ICMJE

November 2010

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01454310 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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:

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

An Acellular Epithelial Skin Substitute in Deep Partial-thickness Burns

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Wound Healing
Scar Formation

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Acellular skin substitute
Intervention: Device: Wound coverage by acellular skin substitute
Active Comparator: Autologous skin graft
Intervention: Device: Autologous skin

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria

Administrative Information

NCT Number ^ICMJE

NCT01454310

Other Study ID Numbers ^ICMJE

SUPRA-VS-STSG-2010

Has Data Monitoring Committee

Responsible Party

Harald Franz Selig, Medical University of Vienna

Study Sponsor ^ICMJE

Medical University of Vienna

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Medical University of Vienna

Verification Date

October 2011

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

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