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Skin Substitutes in Burn Care (Quad)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00676013
First received: December 26, 2007
Last updated: September 6, 2011
Last verified: September 2011
History of Changes
  Purpose

The purpose of this study is to determine if using a DERMAL LAYER under skin grafts:

  1. will reduce scar formation of skin grafts
  2. will reduce burn wound contractures
  3. will improve functional outcome of joints requiring grafts
  4. will reduce healing times and potential complications of donor sites

Compare scarring outcome of Dermal products


Condition Intervention Phase
Burns
 Biological: AlloDerm
Procedure: Skin Biopsy
Biological: Integra
Biological: Autograft
Biological: Homograft
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Alloderm and Other Skin Substitutes in Acute Burn Treatment and Burn Scar Reconstruction

Resource links provided by NLM:

MedlinePlus related topics: Burns Scars
U.S. FDA Resources

Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • Evaluation of dermal products for reduction in the formation of scar [ Time Frame: Time of Burn to 18th birthday ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of dermal products to assess burn wound contractures [ Time Frame: Time of burn to 18th birthday ] [ Designated as safety issue: No ]
  • Evaluation of dermal products for functional outcome of joints requiring grafts [ Time Frame: Time of burn to 18th birthday ] [ Designated as safety issue: No ]
  • Evaluation of dermal products for healing times and potential complications of donor sites [ Time Frame: Time of burn to 18th birthday ] [ Designated as safety issue: No ]

Enrollment: 158
Study Start Date: December 1997
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Use of AlloDerm with grafting
 Biological: AlloDerm
Application of AlloDerm over full thickness burn following excision
Other Names:
  • artificial dermis
  • human dermis
Procedure: Skin Biopsy
Tissue Biopsy of study sites (AlloDerm, Integra, Homograft, Autograft only)
Experimental: 2
Use of Integra with grafting
 Procedure: Skin Biopsy
Tissue Biopsy of study sites (AlloDerm, Integra, Homograft, Autograft only)
Biological: Integra
Application of skin substitute over full thickness burn following excision.
Other Names:
  • Skin substitute
  • Artificial dermis
Experimental: 3
Use of homograft with grafting
 Procedure: Skin Biopsy
Tissue Biopsy of study sites (AlloDerm, Integra, Homograft, Autograft only)
Biological: Homograft
Application of homograft skin over full thickness burn injury following excision of burn wound.
Other Names:
  • cadaver skin
  • donor skin
  • human skin
Active Comparator: 4
Use of autograft only for grafting
 Procedure: Skin Biopsy
Tissue Biopsy of study sites (AlloDerm, Integra, Homograft, Autograft only)
Biological: Autograft
Application of autograft over full thickness burn injury following excision of burn wound.
Other Names:
  • human skin
  • donor site
  • donor skin

  Eligibility

Ages Eligible for Study:   up to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Burn injury requiring grafting
  • 0 years-90 years

Exclusion Criteria:

  • Partial thickness burns only
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676013

Locations
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
University of Texas Medical Branch, Galveston
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: David N Herndon, MD University of Texas
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00676013     History of Changes
Other Study ID Numbers: 97-286
Study First Received: December 26, 2007
Last Updated: September 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:
Burns
Skin grafting
AlloDerm
Integra
 Homograft
Autograft
Burn Scar

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013