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An Acellular Epithelial Skin Substitute in Deep Partial-thickness Burns

NCT01454310 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2011-10-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Lars P Kamolz, MD, PhD, MSc · Medical University of Vienna

  • Maike Keck, MD · Medical University of Vienna, Department of Plastic and Reconstructive Surgery

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-07-31
Completion
2011-09-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01454310 on ClinicalTrials.gov