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Completed

NCT Number: NCT02982096

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients admitted or seen by the LVHN Burn Service with superficial to mid-dermal thickness burns will be considered for the study.
  • Age ≥18 years old.
  • 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

  • Pregnant.
  • Age < 18 years old.
  • Proposed study area on face, neck, genitalia, or feet.

Treatment and study plan

Cellutome Device

Device

Use of FDA approved Cellutome treatment on burn wounds

Standard of care

Other

Acellular burn wound management

Primary outcomes

  1. Healing time comparison of the donor site wound at 12 months post baseline.

    Time frame: 12 months

    Assessed by Vancouver Scar Scale (Vascularity 0-3; Pigmentation 0-3; Pliability 0-5; and Height 0-4)

  2. Healing time comparison of the donor site wound at 12 months post baseline.

    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)

  3. Healing time comparison of the donor site wound at 12 months post baseline.

    Time frame: 12 Months

    Visual assessment of Erythema of the donor site as compared to healthy skin

  4. Healing time comparison of the donor site wound at 12 months post baseline.

    Time frame: 12 Months

    Assessed by measuring Elasticity (measured with cutometer) compared to healthy skin.

  5. Healing time comparison of the donor site wound at 12 months post baseline

    Time frame: 12 Months

    Visual assessment of Pigmentation of the donor site as compared to healthy skin

  6. Healing time comparison of the donor site wound at 12 months post baseline.

    Time frame: 12 Months

    Thickness of donor site (measured by ultrasound) compared to healthy skin

  7. Healing time comparison of the donor site wound at 12 months post baseline.

    Time frame: 12 Months

    Sensation of donor site (measured by the Semmes-Weinstein filament tool) compared to healthy skin

Secondary outcomes

  1. Comparison of visible scarring with the use of the CellutomeTM 12 months post baseline

    Time frame: 12 months

  2. Comparison of impact of therapy on time to healing as assessed by ≥90% epithelialization 12 months post baseline.

    Time frame: 12 months

  3. Comparison of chronic outcomes of therapy 12 months post baseline

    Time frame: 12 Months

    Assessed by the following: Vancouver Scar Scale (Vascularity 0-3; Pigmentation 0-3; Pliability 0-5; and Height 0-4)

  4. Comparison of chronic outcomes of therapy 12 months post baseline

    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)

  5. Comparison of chronic outcomes of therapy 12 months post baseline

    Time frame: 12 Months

    Visual assessment of Erythema of the donor site as compared to healthy skin

  6. Comparison of chronic outcomes of therapy 12 months post baseline

    Time frame: 12 Months

    Visual assessment of Pigmentation of the donor site as compared to healthy skin

  7. Comparison of chronic outcomes of therapy 12 months post baseline

    Time frame: 12 Months

    Elasticity of the donor site (measured with cutometer) compared to healthy skin.

  8. Comparison of chronic outcomes of therapy 12 months post baseline

    Time frame: 12 Months

    Thickness (measured with ultrasound) compared to healthy skin

  9. Comparison of chronic outcomes of therapy 12 months post baseline

    Time frame: 12 Months

    Sensation (measured by Semmes-Weinstein) compared to healthy skin

Sponsors and collaborators

Lead sponsor

Lehigh Valley Hospital

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Dec 5, 2016
Registry last updated
Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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