An Acellular Epithelial Skin Substitute in Deep Partial-thickness Burns

NCT01454310 | Completed Phase 4

• 1 other identifier: SUPRA-VS-STSG-2010
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Healing; Scar Formation

Keywords

Skin substitutes; Split-thickness skin graft; Burn wound; Scar formation; Skin quality

Outcome Measures

Primary Outcomes (1)

• Time (in days +/- standarddeviation) to complete re-epithelialisation in acellular skin substitue area versus autologous skin

  Time to complete re-epithelialisation measured in days after surgery

  1 year

Secondary Outcomes (1)

• Skin quality- ratio acellular skin substitute/healthy skin versus ratio autologous skin/healthy skin

  1 year

Study Arms (2)

Acellular skin substitute

EXPERIMENTAL

Device: Wound coverage by acellular skin substitute

Autologous skin graft

ACTIVE COMPARATOR

Device: Autologous skin

Interventions

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

Also known as: Suprathel

Acellular skin substitute

Autologous skin DEVICE

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

Autologous skin graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years of age
• verified deep partial-thickness burns
• early tangential excision of burn wound (3-5 days after trauma)

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

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

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

• Uhlig C, Rapp M, Hartmann B, Hierlemann H, Planck H, Dittel KK. Suprathel-an innovative, resorbable skin substitute for the treatment of burn victims. Burns. 2007 Mar;33(2):221-9. doi: 10.1016/j.burns.2006.04.024. Epub 2006 Nov 2.

  PMID: 17084030 BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Lars P Kamolz, MD, PhD, MSc

  Medical University of Vienna

  STUDY CHAIR

• Maike Keck, MD

  Medical University of Vienna, Department of Plastic and Reconstructive Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, research assistant

Study Record Dates

• First Submitted: October 15, 2011
• First Posted: October 19, 2011
• Study Start: November 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 19, 2011

Record last verified: 2011-10

Locations

AU (1)