An Acellular Epithelial Skin Substitute in Deep Partial-thickness Burns

October 18, 2011 updated by: Harald Franz Selig, Medical University of Vienna

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna, Burn Center, Department of Plastic and Reconstructive Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Suprathel
Active Comparator: Autologous skin graft
Device: Autologous skin
Matched burn wound is covered by autologous skin after tangential excision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

October 15, 2011

First Submitted That Met QC Criteria

October 18, 2011

First Posted (Estimate)

October 19, 2011

Study Record Updates

Last Update Posted (Estimate)

October 19, 2011

Last Update Submitted That Met QC Criteria

October 18, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SUPRA-VS-STSG-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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