An Acellular Epithelial Skin Substitute in Deep Partial-thickness Burns

Phase 4

Completed

• Conditions: Wound Healing; Scar Formation
• Interventions: Device: Autologous skin; Device: Wound coverage by acellular skin substitute

• Registration Number: NCT01454310
• Lead Sponsor: Medical University of Vienna

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2011-07
• Study Completion: 2011-09
• Status Verified: 2011-10
• Study First Submitted: 2011-10-15
• Study First Submitted QC: 2011-10-18
• Last Update Submitted: 2011-10-18
• Study First Posted: 2011-10-19
• Last Update Posted: 2011-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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)

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Exclusion Criteria

• Pregnancy
• ABSI-Score >13
• Active tumor or immune-mediated disease
• Patient refusal

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous skin graft	Autologous skin	-
Acellular skin substitute	Wound coverage by acellular skin substitute	-

Primary Outcome Measures

Name	Time	Method
Time (in days +/- standarddeviation) to complete re-epithelialisation in acellular skin substitue area versus autologous skin	1 year	Time to complete re-epithelialisation measured in days after surgery

Secondary Outcome Measures

Name	Time	Method
Skin quality- ratio acellular skin substitute/healthy skin versus ratio autologous skin/healthy skin	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.

Trial Locations

Locations (1)

Medical University of Vienna, Burn Center, Department of Plastic and Reconstructive Surgery; 🇦🇹 Vienna, Austria