Burn Wound
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DEVICECellutome Device
Use of FDA approved Cellutome treatment on burn wounds
OTHERStandard of Care
Acellular burn wound management
Sponsors
Lehigh Valley Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients admitted or seen by the LVHN Burn Service with superficial to mid-dermal thickness burns will be considered for the study. 2. Age ≥18 years old. 3. Patients with a total body surface area (TBSA) burn \> 1% outside of the face, neck, feet or genitalia, where at least 2 areas are greater in size than 5x5cm2 or at least one area that is greater than 10cm2
Exclusion criteria
1. Pregnant. 2. Age \< 18 years old. 3. Proposed study area on face, neck, genitalia, or feet.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing time comparison of the donor site wound at 12 months post baseline. | 12 months | Assessed by Vancouver Scar Scale (Vascularity 0-3; Pigmentation 0-3; Pliability 0-5; and Height 0-4) |
| Healing time comparison of the donor site wound at 12 months post baseline | 12 Months | Visual assessment of Pigmentation of the donor site as compared to healthy skin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of visible scarring with the use of the CellutomeTM 12 months post baseline | 12 months | — |
| Comparison of impact of therapy on time to healing as assessed by ≥90% epithelialization 12 months post baseline. | 12 months | — |
| Comparison of chronic outcomes of therapy 12 months post baseline | 12 Months | Assessed by the following: Vancouver Scar Scale (Vascularity 0-3; Pigmentation 0-3; Pliability 0-5; and Height 0-4) |
Countries
United States
Outcome results
None listed