Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique

Study Overview
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Brief Summary
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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
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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).

Official Title
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Randomized Controlled Pilot Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique (Membrane or Cream Dressings) in Superficial to Mid-dermal Burn Wounds

Conditions
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Burn Wound

Intervention / Treatment
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* Device: Cellutome Device
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted or seen by the LVHN Burn Service with superficial to mid-dermal thickness burns will be considered for the study. Age ≥18 years old. 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: Pregnant. Age < 18 years old. Proposed study area on face, neck, genitalia, or feet.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cellutome treatment<br>Cellutome Device: Use of Cellutome on burn wounds | Device: Cellutome Device<br>* Use of FDA approved Cellutome treatment on burn wounds<br>|
| Other: Standard of Care<br>Standard of Care: Acellular wound management | Other: Standard of Care<br>* Acellular burn wound management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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 | 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. | 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 | 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 | 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 | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Assessed by the following: Vancouver Scar Scale (Vascularity 0-3; Pigmentation 0-3; Pliability 0-5; and Height 0-4) | 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) | 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 | 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 | 12 Months | 
| Comparison of chronic outcomes of therapy 12 months post baseline | Elasticity of the donor site (measured with cutometer) compared to healthy skin. | 12 Months | 
| Comparison of chronic outcomes of therapy 12 months post baseline | Thickness (measured with ultrasound) compared to healthy skin | 12 Months | 
| Comparison of chronic outcomes of therapy 12 months post baseline | Sensation (measured by Semmes-Weinstein) compared to healthy skin | 12 Months |