Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cellutome treatment | Active Comparator | Cellutome Device: Use of Cellutome on burn wounds |
|
| Standard of Care | Other | Standard of Care: Acellular wound management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cellutome Device | Device | Use of FDA approved Cellutome treatment on burn wounds |
| |
| 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. |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sigrid Blome-Eberwein, MD | Lehigh Valley Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 19, 2023 | |
| Reset | Jan 10, 2024 | |
| Release | Oct 7, 2024 | |
| Reset | Oct 30, 2024 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 19, 2023 | Jan 10, 2024 | |||
| Oct 7, 2024 |
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard of Care |
| Other |
Acellular burn wound management |
|
Sensation of donor site (measured by the Semmes-Weinstein filament tool) compared to healthy skin
| 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 |
| Oct 30, 2024 |