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Sponsored by: |
The University of Texas, Galveston |
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Information provided by: | The University of Texas, Galveston |
ClinicalTrials.gov Identifier: | NCT00676013 |
The purpose of this study is to determine if using a DERMAL LAYER under skin grafts:
Compare scarring outcome of Dermal products
Condition | Intervention | Phase |
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Burns |
Biological: AlloDerm Procedure: Skin Biopsy Biological: Integra Biological: Autograft Biological: Homograft |
Phase II Phase III |
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 |
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 |
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1: Experimental
Use of AlloDerm with grafting
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Biological: AlloDerm
Application of AlloDerm over full thickness burn following excision
Procedure: Skin Biopsy
Tissue Biopsy of study sites (AlloDerm, Integra, Homograft, Autograft only)
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2: Experimental
Use of Integra with grafting
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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.
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3: Experimental
Use of homograft with grafting
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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.
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4: Active Comparator
Use of autograft only for grafting
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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.
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Ages Eligible for Study: | up to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David N Herndon, MD | 409-770-6731 | dherndon@utmb.edu |
Contact: Deb A Benjamin, RN, MSN | 409-770-6731 | dbenjami@utmb.edu |
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 |
Principal Investigator: | David N Herndon, MD | University of Texas |
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 |
Burns Skin grafting AlloDerm Integra |
Homograft Autograft Burn Scar |
Burns Wounds and Injuries Disorders of Environmental Origin Cicatrix |