Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
NCT Number: NCT02982096
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Allentown, Pennsylvania, 18103, United States
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of FDA approved Cellutome treatment on burn wounds
Acellular burn wound management
Time frame: 12 months
Assessed by Vancouver Scar Scale (Vascularity 0-3; Pigmentation 0-3; Pliability 0-5; and Height 0-4)
Time frame: 12 Months
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
Visual assessment of Erythema of the donor site as compared to healthy skin
Time frame: 12 Months
Assessed by measuring Elasticity (measured with cutometer) compared to healthy skin.
Time frame: 12 Months
Visual assessment of Pigmentation of the donor site as compared to healthy skin
Time frame: 12 Months
Thickness of donor site (measured by ultrasound) compared to healthy skin
Time frame: 12 Months
Sensation of donor site (measured by the Semmes-Weinstein filament tool) compared to healthy skin
Time frame: 12 months
Time frame: 12 months
Time frame: 12 Months
Assessed by the following: Vancouver Scar Scale (Vascularity 0-3; Pigmentation 0-3; Pliability 0-5; and Height 0-4)
Time frame: 12 Months
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
Visual assessment of Erythema of the donor site as compared to healthy skin
Time frame: 12 Months
Visual assessment of Pigmentation of the donor site as compared to healthy skin
Time frame: 12 Months
Elasticity of the donor site (measured with cutometer) compared to healthy skin.
Time frame: 12 Months
Thickness (measured with ultrasound) compared to healthy skin
Time frame: 12 Months
Sensation (measured by Semmes-Weinstein) compared to healthy skin
Lehigh Valley Hospital
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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