Clinical trial NCT02982096: Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn Wound
Lead sponsor: Lehigh Valley Hospital
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Healing time comparison of the donor site wound at 12 months post baseline.
timeFrame: 12 months
measure: Healing time comparison of the donor site wound at 12 months post baseline.
timeFrame: 12 Months
measure: Healing time comparison of the donor site wound at 12 months post baseline.
timeFrame: 12 Months
measure: Healing time comparison of the donor site wound at 12 months post baseline.
timeFrame: 12 Months
measure: Healing time comparison of the donor site wound at 12 months post baseline
timeFrame: 12 Months
measure: Healing time comparison of the donor site wound at 12 months post baseline.
timeFrame: 12 Months
measure: Healing time comparison of the donor site wound at 12 months post baseline.
timeFrame: 12 Months
Secondary outcomes:
measure: Comparison of visible scarring with the use of the CellutomeTM 12 months post baseline
timeFrame: 12 months
measure: Comparison of impact of therapy on time to healing as assessed by ≥90% epithelialization 12 months post baseline.
timeFrame: 12 months
measure: Comparison of chronic outcomes of therapy 12 months post baseline
timeFrame: 12 Months
measure: Comparison of chronic outcomes of therapy 12 months post baseline
timeFrame: 12 Months
measure: Comparison of chronic outcomes of therapy 12 months post baseline
timeFrame: 12 Months
measure: Comparison of chronic outcomes of therapy 12 months post baseline
timeFrame: 12 Months
measure: Comparison of chronic outcomes of therapy 12 months post baseline
timeFrame: 12 Months
measure: Comparison of chronic outcomes of therapy 12 months post baseline
timeFrame: 12 Months
measure: Comparison of chronic outcomes of therapy 12 months post baseline
timeFrame: 12 Months
Other outcomes:
Locations:
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
Study officials:
affiliation: Lehigh Valley Health Network
name: Sigrid Blome-Eberwein, MD
role: PRINCIPAL_INVESTIGATOR
References: