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Skin Substitutes in Burn Care (Quad)
This study is currently recruiting participants.
Verified by The University of Texas, Galveston, May 2008
Sponsored by: The University of Texas, Galveston
Information provided by: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00676013
  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 II
Phase III

MedlinePlus related topics: Burns Scars
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title: The Use of Alloderm and Other Skin Substitutes in Acute Burn Treatment and Burn Scar Reconstruction

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 ]

Estimated Enrollment: 200
Study Start Date: December 1997
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Use of AlloDerm with grafting
Biological: AlloDerm
Application of AlloDerm over full thickness burn following excision
Procedure: Skin Biopsy
Tissue Biopsy of study sites (AlloDerm, Integra, Homograft, Autograft only)
2: Experimental
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.
3: Experimental
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.
4: Active Comparator
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.

  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

Contacts
Contact: David N Herndon, MD 409-770-6731 dherndon@utmb.edu
Contact: Deb A Benjamin, RN, MSN 409-770-6731 dbenjami@utmb.edu

Locations
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Deb A Benjamin, RN, MSN     409-770-6731     dbenjami@utmb.edu    
Contact: Carole J Miller     409-770-6728     cmiller@utmb.edu    
Principal Investigator: David N Herndon, MD            
University of Texas Medical Branch, Galveston Recruiting
Galveston, Texas, United States, 77555
Contact: Deb A Benjamin, RN, MSN     409-770-6731     dbenjami@utmb.edu    
Contact: Carole J Miller     409-770-6728     cmiller@utmb.edu    
Principal Investigator: David N Herndon, MD            
Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: David N Herndon, MD University of Texas
  More Information

Responsible Party: University of Texas Medical Branch, Galveston ( David N. Herndon, MD )
Study ID Numbers: 97-286
Study First Received: December 26, 2007
Last Updated: May 7, 2008
ClinicalTrials.gov Identifier: NCT00676013  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Burns
Wounds and Injuries
Disorders of Environmental Origin
Cicatrix

ClinicalTrials.gov processed this record on January 16, 2009



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