Study Stopped
Unable to continue study following Hurricane Ike.
Comparison of Skin Substitutes Used in Burn Care
Quad
The Use of Alloderm and Other Skin Substitutes in Acute Burn Treatment and Burn Scar Reconstruction
1 other identifier
interventional
158
1 country
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 1997
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1997
CompletedFirst Submitted
Initial submission to the registry
December 26, 2007
CompletedFirst Posted
Study publicly available on registry
May 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
December 16, 2019
CompletedDecember 16, 2019
August 1, 2018
13.1 years
December 26, 2007
August 6, 2012
November 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Burn Scar Comparison
Burn scar is measured scar using the Vancouver Scar Scale (range 0-12) for each of the various skin substitutes used in grafting. Vancouver Scar Scale measure burn scarring assessing categories of redness/vascularity, hardness, pigmentation and scar height. Each item has a scale of 0-3. Score for each category is summed together for a total score between 0-12. The total score is generally used in the burn community, therefore the total score will be reported. Lower scores are better; higher scores are worse.
2 years post burn injury
Study Arms (1)
Alloderm, Integra, Homograft, Autograft
EXPERIMENTALBurn debridement and grafting using interventions of 1) AlloDerm, 2) Integra, 3) Homograft and 4) Autograft on four separate sites on each patient
Interventions
Grafting using the Commercial product Integra as a skin substitute over full thickness burn following excision.
Grafting using the commercial product AlloDerm as a skin substitute
Grafting using homograft as a skin substitute
grafting using patients own skin from a separate donor site
Eligibility Criteria
You may qualify if:
- Burn injury requiring grafting
- years-90 years
You may not qualify if:
- Partial thickness burns only
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Texas Medical Branch, Galveston
Galveston, Texas, 77555, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Herndon, MD
- Organization
- University of Texas Medical Branch
Study Officials
- PRINCIPAL INVESTIGATOR
David N Herndon, MD
University of Texas
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2007
First Posted
May 12, 2008
Study Start
December 1, 1997
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
December 16, 2019
Results First Posted
December 16, 2019
Record last verified: 2018-08