The purpose of this study is to determine if healing occurs within 21 days of treatment with the use of the CellutomeTM device for fractional epidermal micro grafting compared with standard acellular techniques (creams and membrane dressings). Healing will be determined by time to ≥90% epithelialization within 21 days of treatment. Cosmesis (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation, elasticity, thickness, and sensation) will be compared to standard techniques without application of skin cells (epidermal grafts = acellular) and will be measured twelve months post treatment application, ± 6 months.
Hypothesis: The use of epidermal blister grafting by the CellutomeTM device in the treatment of superficial and mid-dermal burn wounds will demonstrate a difference in time to healing compared to burn wounds treated with standard acellular technique. Primary objective: Determine if the use of the CellutomeTM device will demonstrate a difference in healing time compared to standard acellular technique. Final cosmetic outcomes (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation, elasticity, thickness, and sensation) will be assessed and described at 12 months ± 6 months post treatment. Secondary objectives: * Determine if donor sites have any visible scarring with the use of the CellutomeTM. * Determine acute outcomes of therapy such as time to healing as assessed by ≥90% epithelialization. * Determine chronic outcomes of therapy (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation, elasticity, thickness, and sensation).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Use of FDA approved Cellutome treatment on burn wounds
Acellular burn wound management
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Healing time comparison of the donor site wound at 12 months post baseline.
Assessed by Vancouver Scar Scale (Vascularity 0-3; Pigmentation 0-3; Pliability 0-5; and Height 0-4)
Time frame: 12 months
Healing time comparison of the donor site wound at 12 months post baseline.
Assessed by Patient Observer Scar Assessment Scale (POSAS - evaluating patient perception of the scar including pain; itching; color; stiffness; thickness; irregularity on a 1-10 Likert Scale)
Time frame: 12 Months
Healing time comparison of the donor site wound at 12 months post baseline.
Visual assessment of Erythema of the donor site as compared to healthy skin
Time frame: 12 Months
Healing time comparison of the donor site wound at 12 months post baseline.
Assessed by measuring Elasticity (measured with cutometer) compared to healthy skin.
Time frame: 12 Months
Healing time comparison of the donor site wound at 12 months post baseline
Visual assessment of Pigmentation of the donor site as compared to healthy skin
Time frame: 12 Months
Healing time comparison of the donor site wound at 12 months post baseline.
Thickness of donor site (measured by ultrasound) compared to healthy skin
Time frame: 12 Months
Healing time comparison of the donor site wound at 12 months post baseline.
Sensation of donor site (measured by the Semmes-Weinstein filament tool) compared to healthy skin
Time frame: 12 Months
Comparison of visible scarring with the use of the CellutomeTM 12 months post baseline
Time frame: 12 months
Comparison of impact of therapy on time to healing as assessed by ≥90% epithelialization 12 months post baseline.
Time frame: 12 months
Comparison of chronic outcomes of therapy 12 months post baseline
Assessed by the following: Vancouver Scar Scale (Vascularity 0-3; Pigmentation 0-3; Pliability 0-5; and Height 0-4)
Time frame: 12 Months
Comparison of chronic outcomes of therapy 12 months post baseline
Patient Observer Scar Assessment Scale (POSAS - evaluating patient perception of the scar including pain; itching; color; stiffness; thickness; irregularity on a 1-10 Likert Scale)
Time frame: 12 Months
Comparison of chronic outcomes of therapy 12 months post baseline
Visual assessment of Erythema of the donor site as compared to healthy skin
Time frame: 12 Months
Comparison of chronic outcomes of therapy 12 months post baseline
Visual assessment of Pigmentation of the donor site as compared to healthy skin
Time frame: 12 Months
Comparison of chronic outcomes of therapy 12 months post baseline
Elasticity of the donor site (measured with cutometer) compared to healthy skin.
Time frame: 12 Months
Comparison of chronic outcomes of therapy 12 months post baseline
Thickness (measured with ultrasound) compared to healthy skin
Time frame: 12 Months
Comparison of chronic outcomes of therapy 12 months post baseline
Sensation (measured by Semmes-Weinstein) compared to healthy skin
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Time frame: 12 Months