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

Lehigh Valley Hospital

Status: Completed

Conditions: Burn Wound

Treatments: Device: Cellutome Device; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02982096

PRO00003893

Details and patient eligibility

About

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.

Full 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).

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Cellutome treatment

Active Comparator group

Description:

Cellutome Device: Use of Cellutome on burn wounds

Treatment:

Device: Cellutome Device

Standard of Care

Other group

Description:

Standard of Care: Acellular wound management

Treatment:

Other: Standard of Care