About 20 participants will be enrolled in this trial if they have had an accident that damages both the dermal (outside) and epidermal (inside) layers of skin on up to 49% of their body. This condition is called full-thickness complex skin defects resulting from acute traumatic skin loss. Participants will be treated with StrataGraft skin tissue to evaluate it's safety and effectiveness for use in treating full-thickness complex skin defects.
The objective of this range-finding study was to assess the safety, tolerability, and efficacy of single or repeated application of StrataGraft skin tissue in full-thickness complex skin defects resulting from acute traumatic skin loss (eg, thermal burns or degloving injuries) requiring surgical excision and autografting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).
The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.
Arizona Burn Center
Phoenix, Arizona, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
U.S. Army Institute of Surgical Research Adult Burn Center
Fort Sam Houston, Texas, United States
University of Wisconsin Hospital
Madison, Wisconsin, United States
Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months
The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined.
Time frame: 3 months
Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months
Complete wound closure is defined as ≥95% re-epithelialization of all treatment sites with the absence of drainage
Time frame: 3 months
Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months
Time frame: within 3 months
Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months
Time frame: within 3, 6 and 12 months
Percent Wound Closure at 3, 6, and 12 Months
Time frame: within 3, 6, and 12 Months
Cosmesis of Treatment Sites at 3, 6, and 12 Months
Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance
Time frame: within 3, 6, and 12 Months
Cosmesis of Donor Sites at 3, 6, and 12 Months
Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance
Time frame: within 3, 6, and 12 Months
Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28
Time frame: at days 3, 7, 14, 21, and 28
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