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Comparison of Skin Substitutes Used in Burn Care (Quad)

Primary Purpose

Burns

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integra
AlloDerm
Homograft
Autograft
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Burns, Skin grafting, AlloDerm, Integra, Homograft, Autograft, Burn Scar

Eligibility Criteria

undefined - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Burn injury requiring grafting
  • 0 years-90 years

Exclusion Criteria:

  • Partial thickness burns only

Sites / Locations

  • University of Texas Medical Branch, Galveston
  • University of Texas Medical Branch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alloderm, Integra, Homograft, Autograft

Arm Description

Burn debridement and grafting using interventions of 1) AlloDerm, 2) Integra, 3) Homograft and 4) Autograft on four separate sites on each patient

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 26, 2007
Last Updated
November 26, 2019
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT00676013
Brief Title
Comparison of Skin Substitutes Used in Burn Care
Acronym
Quad
Official Title
The Use of Alloderm and Other Skin Substitutes in Acute Burn Treatment and Burn Scar Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Unable to continue study following Hurricane Ike.
Study Start Date
December 1997 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine if using a DERMAL LAYER under skin grafts: will reduce scar formation of skin grafts will reduce burn wound contractures will improve functional outcome of joints requiring grafts Compare scarring outcome of Dermal products
Detailed Description
Various skin substitutes are compared for healing, scar and functional and cosmetic outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Burns, Skin grafting, AlloDerm, Integra, Homograft, Autograft, Burn Scar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alloderm, Integra, Homograft, Autograft
Arm Type
Experimental
Arm Description
Burn debridement and grafting using interventions of 1) AlloDerm, 2) Integra, 3) Homograft and 4) Autograft on four separate sites on each patient
Intervention Type
Procedure
Intervention Name(s)
Integra
Other Intervention Name(s)
Artificial dermis
Intervention Description
Grafting using the Commercial product Integra as a skin substitute over full thickness burn following excision.
Intervention Type
Procedure
Intervention Name(s)
AlloDerm
Other Intervention Name(s)
Cadaver skin
Intervention Description
Grafting using the commercial product AlloDerm as a skin substitute
Intervention Type
Procedure
Intervention Name(s)
Homograft
Other Intervention Name(s)
Cadaver Skin
Intervention Description
Grafting using homograft as a skin substitute
Intervention Type
Procedure
Intervention Name(s)
Autograft
Intervention Description
grafting using patients own skin from a separate donor site
Primary Outcome Measure Information:
Title
Burn Scar Comparison
Description
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.
Time Frame
2 years post burn injury

10. Eligibility

Sex
All
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Burn injury requiring grafting 0 years-90 years Exclusion Criteria: Partial thickness burns only
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David N Herndon, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Medical Branch, Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparison of Skin Substitutes Used in Burn Care

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