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Completed

NCT Number: NCT01454310

An Acellular Epithelial Skin Substitute 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.

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Key information

Conditions

Wound Healing Burns Scar Formation Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wound coverage by acellular skin substitute

Device

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

Autologous skin

Device

Matched burn wound is covered by autologous skin after tangential excision.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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:

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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 19, 2011
Registry last updated
Oct 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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