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

NCT02982096 | Completed

• 1 other identifier: PRO00003893
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Wound

Outcome Measures

Primary Outcomes (7)

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

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

  12 months

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

  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)

  12 Months

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

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

  12 Months

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

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

  12 Months

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

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

  12 Months

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

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

  12 Months

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

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

  12 Months

Secondary Outcomes (9)

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

  12 months

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

  12 months

• Comparison of chronic outcomes of therapy 12 months post baseline

  12 Months

• Comparison of chronic outcomes of therapy 12 months post baseline

  12 Months

• Comparison of chronic outcomes of therapy 12 months post baseline

  12 Months

Study Arms (2)

Cellutome treatment

ACTIVE COMPARATOR

Cellutome Device: Use of Cellutome on burn wounds

Device: Cellutome Device

Standard of Care

OTHER

Standard of Care: Acellular wound management

Other: Standard of Care

Interventions

Cellutome Device DEVICE

Use of FDA approved Cellutome treatment on burn wounds

Cellutome treatment

Standard of Care OTHER

Acellular burn wound management

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lehigh Valley Hospital: lead

Study Sites (1)

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sigrid Blome-Eberwein, MD

  Lehigh Valley Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: December 5, 2016
• Study Start: August 23, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 10, 2023

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)