The purpose of this study is to determine if using a DERMAL LAYER under skin grafts will: Reduce scar formation of skin graftsReduce burn wound contracturesImprove functional outcome of joints requiring graftsReduce healing times and potential complications of donor sitesCompare scarring outcome of Dermal products.

Official Title

The Use of Alloderm and Other Skin Substitutes in Acute Burn Treatment and Burn Scar Reconstruction.

Conditions

  • Burns

Study Type

Interventional

Study Design

Treatment, Randomised, Open Label, Active Control, Factorial Assignment, Efficacy Study.

Further Details

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]

Study Start

December 1997

Eligibility & Criteria

  • Ages Eligible for Study: up to 90 Years
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Burn injury requiring grafting
  • 0 years-90 years

Exclusion Criteria:

  • Partial thickness burns only

Total Enrolment

200

Contact Details

David N Herndon, MD
409-770-6731
dherndon@utmb.edu   

Deb A Benjamin, RN, MSN
409-770-6731
dbenjami@utmb.edu