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NCT00676013 Clinical Trial

Comparison of Skin Substitutes Used in Burn Care

Burns Clinical Trial

— Quad  

Official title:
The Use of Alloderm and Other Skin Substitutes in Acute Burn Treatment and Burn Scar Reconstruction

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00676013
Other study ID # 97-286
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 1997
Est. completion date January 2011

Study information
Verified date August 2018
Source The University of Texas Medical Branch, Galveston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Compare scarring outcome of Dermal products

Description:

Various skin substitutes are compared for healing, scar and functional and cosmetic outcomes.

Recruitment information / eligibility
Status Terminated
Enrollment 158
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender All
Age group N/A to 90 Years
Eligibility Inclusion Criteria:

- Burn injury requiring grafting

- 0 years-90 years

Exclusion Criteria:

- Partial thickness burns only

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Integra
Grafting using the Commercial product Integra as a skin substitute over full thickness burn following excision.
• AlloDerm
Grafting using the commercial product AlloDerm as a skin substitute
• Homograft
Grafting using homograft as a skin substitute
• Autograft
grafting using patients own skin from a separate donor site

Locations
Country Name City State
United States University of Texas Medical Branch Galveston Texas
United States University of Texas Medical Branch, Galveston Galveston Texas

Sponsors (1)
Lead Sponsor Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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