Fractional Ablative Laser Treatment for Skin Grafts

NCT04176705 | Completed Results DMC FDA Device

• 1 other identifier: IRB00058363
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Doctors and patients refer to all areas of skin changes from burn injury as burn scars. However, different areas of scars from burns can be treated differently. The burn scars that come from skin grafting surgery might be improved with laser treatment. The purpose of this study is to see if treating burn skin graft scars with a laser could make it better. Fractional Ablative Laser has been approved by the US Food and Drug Administration (FDA), but it has not been approved for use in the early stages of scar maturation and is considered investigational for this study.

Conditions

Burn Scar; Skin Graft Scar

Keywords

Fractional laser; Ablative Laser; Carbon Dioxide Laser

Outcome Measures

Primary Outcomes (2)

• Contracture of Scar Surface Area (Percentage of Original Area)

  Contracture of Scar Surface Area 90 days post grafting: The surface area of the skin graft cm\^2 at about 90 days after skin grafting will be compared to the size of the original skin graft at about one week after surgery.

  90 days post-grafting

• Contracture of Scar Surface Area (Percentage of Original Area)

  Contracture of Scar Surface Area 1 year post grafting: The surface area of the skin graft cm\^2 at about one year after skin grafting will be compared to the size of the original skin graft at about one week after surgery.

  1 year post-grafting

Secondary Outcomes (16)

• Scar Roughness

  90 days post-grafting

• Scar Roughness

  1 year post-grafting

• Biomechanics Stiffness

  90 days post-grafting

• Biomechanics Stiffness

  1 year post-grafting

• Biomechanics Elasticity

  90 days post-grafting

Study Arms (2)

Laser

EXPERIMENTAL

Split person design. Each participant had a skin burn area that was treated with the laser and a skin burn area that was not treated with the laser.

Drug: Lidocaine Cream; Drug: Triamcinolone Acetonide Cream; Device: Fractional Ablative Laser

No laser

PLACEBO COMPARATOR

Split person design. Each participant had a skin burn area that was treated with the laser and a skin burn area that was not treated with the laser.

Drug: Lidocaine Cream; Drug: Triamcinolone Acetonide Cream

Interventions

Lidocaine Cream DRUG

Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.

Laser; No laser

Triamcinolone Acetonide Cream DRUG

Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.

Laser; No laser

Fractional Ablative Laser DEVICE

Applied to only site that is randomized to laser intervention

Laser

Eligibility Criteria

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

You may qualify if:

• Patients who are to undergo skin grafting procedures for acute treatment of thermal burns.
• Patients with grafts placed over at least 100cm\^2

You may not qualify if:

• Patients who have are not scheduled to undergo skin grafting procedures
• Patients who have grafts placed under 100cm\^2

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Results Point of Contact

• Title: John Bailey, MD
• Organization: Wake Forest University Health Sciences

jkbailey@wakehealth.edu

(336) 716-8002

Study Officials

• John Bailey, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 20, 2019
• First Posted: November 25, 2019
• Study Start: December 14, 2020
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: November 29, 2024
• Results First Posted: November 29, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available within 6 months of data completion.
• Access Criteria: Research groups with authors who have at least one related publication

Locations

US (1)