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

Burn Wound Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982096
• Other study ID #: PRO00003893
• Status: Completed
• Phase: N/A
• Start date: August 23, 2016
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2021
• Source: Lehigh Valley Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Burn Wound
• Burns

Intervention

Device:
• Cellutome Device
Use of FDA approved Cellutome treatment on burn wounds

Other:
• Standard of Care
Acellular burn wound management

Locations

Country	Name	City	State
United States	Lehigh Valley Health Network	Allentown	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Lehigh Valley Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Comparison of visible scarring with the use of the CellutomeTM 12 months post baseline		12 months
Secondary	Comparison of impact of therapy on time to healing as assessed by =90% epithelialization 12 months post baseline.		12 months
Secondary	Comparison of chronic outcomes of therapy 12 months post baseline	Assessed by the following: Vancouver Scar Scale (Vascularity 0-3; Pigmentation 0-3; Pliability 0-5; and Height 0-4)	12 Months
Secondary	Comparison of chronic outcomes of therapy 12 months post baseline	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
Secondary	Comparison of chronic outcomes of therapy 12 months post baseline	Visual assessment of Erythema of the donor site as compared to healthy skin	12 Months
Secondary	Comparison of chronic outcomes of therapy 12 months post baseline	Visual assessment of Pigmentation of the donor site as compared to healthy skin	12 Months
Secondary	Comparison of chronic outcomes of therapy 12 months post baseline	Elasticity of the donor site (measured with cutometer) compared to healthy skin.	12 Months
Secondary	Comparison of chronic outcomes of therapy 12 months post baseline	Thickness (measured with ultrasound) compared to healthy skin	12 Months
Secondary	Comparison of chronic outcomes of therapy 12 months post baseline	Sensation (measured by Semmes-Weinstein) compared to healthy skin	12 Months