Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | November 2016 |
| End Date: | January 2019 |
| Contact: | Leslie Baga |
| Email: | leslie.baga@lvhn.org |
| Phone: | 610 402-1285 |
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
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.
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).
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).
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.
We found this trial at
1
site
Allentown, Pennsylvania 18105
Principal Investigator: Sigrid Blome-Eberwein, MD
Phone: 610-402-1285
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