NCT01454310

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wound Healing
• Scar Formation

Interventions

Type	Name	Description
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
DEVICE	Autologous skin	Matched burn wound is covered by autologous skin after tangential excision.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-07-01
• Completion: 2011-09-01
• First posted: 2011-10-19
• Last updated: 2011-10-19

Locations

1 site across 1 country: Austria