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

NCT ID: NCT02982096

Last Updated: 2023-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-23
• Study Completion Date: 2022-12-01

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).

Conditions

Burn Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cellutome treatment

Cellutome Device: Use of Cellutome on burn wounds

Group Type: ACTIVE_COMPARATOR

Cellutome Device

Intervention Type: DEVICE

Use of FDA approved Cellutome treatment on burn wounds

Standard of Care

Standard of Care: Acellular wound management

Group Type: OTHER

Standard of Care

Intervention Type: OTHER

Acellular burn wound management

Interventions

Cellutome Device

Use of FDA approved Cellutome treatment on burn wounds

Intervention Type: DEVICE

Standard of Care

Acellular burn wound management

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lehigh Valley Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sigrid Blome-Eberwein, MD

Role: PRINCIPAL_INVESTIGATOR

Lehigh Valley Health Network

Locations

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO00003893

Identifier Type: -

Identifier Source: org_study_id