Fractional Ablative Laser Treatment for Skin Grafts

Pilot Study of Early Postoperative Fractional Ablative Laser Treatment of Skin Grafts for Burns

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.

Study Overview

• Status: Completed
• Conditions: Burn Scar; Skin Graft Scar
• Intervention / Treatment: Drug: Lidocaine Cream; Drug: Triamcinolone Acetonide Cream; Device: Fractional Ablative Laser

Detailed Description

This pilot study is being conducted to establish safety, however the study team will make multiple measures to measure for efficacy as well. The study team hypothesizes that human split-thickness skin grafts will safely respond similar to the porcine model when treated with the Fractional Carbon Dioxide (FxCO2) laser and have significantly less secondary contracture than control sites. The great majority of laser studies have addressed treatment of established scars. Ideally, treatment modalities could be moved into the acute period of injury, to shorten the recovery time of thermal burns by decreasing the time to maximum recovery, and mitigate scar formation. The current study will address the impact on treatment of skin graft applied in the treatment of acute burn wounds. Preliminary work completed by our team has confirmed that the red Duroc porcine model is a good model of hypertrophic scar formation in humans, and early use of the FxCO2 on split-thickness skin grafts decreased secondary contracture. Further, the study team has identified a period of 19 weeks between the time custom-made compression garments are ordered and actually applied with benefit to the patient. The study team has identified a "therapeutic donut hole" in which they have no efficacious alternative to offer until about 19 weeks. In these patients who had larger burn returning to the OR for additional procedures, the study team was able to offer FxCO2 treatment as a "salvage" therapy. With this, the study team has demonstrated safety for the skin graft and anecdotal efficacy. The study team proposes a pilot study to prospectively demonstrate safety in a controlled study and attempt to establish efficacy of early (post grafting day 7-10) FxCO2 laser treatment of split-thickness skin graft applied in the treatment of burn injuries.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser; 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; 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.; Drug: Triamcinolone Acetonide Cream; 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.; Device: Fractional Ablative Laser; Applied to only site that is randomized to laser intervention
Placebo Comparator: No laser; 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; 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.; Drug: Triamcinolone Acetonide Cream; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar Roughness	Scar Roughness at 9 weeks and 12 weeks post grafting: will be quantified using a mold/casting technique using Aquasil Ultra XLV dental impression material followed by mold imaging and quantitative analysis. A three-dimensional analysis of the molds will allow for measure of average roughness. The machine used will provide a digital read out which will then be averaged to obtain a mean value. This will allow for comparison between treated and control grafts at 90 days and one year.	90 days post-grafting
Scar Roughness	Scar Roughness 10-12 months post grafting: will be quantified using a mold/casting technique using Aquasil Ultra XLV dental impression material followed by mold imaging and quantitative analysis. A three-dimensional analysis of the molds will allow for measure of average roughness. The machine used will provide a digital read out that will then be averaged to obtain a mean value. This will allow for comparison between treated and control grafts at 90 days and one year.	1 year post-grafting
Biomechanics Stiffness	Biomechanics Stiffness 90 days post grafting: The BTC-2000 device uses a laser to measure skin deflection as negative atmospheric pressure is applied and this allows for quantification of the skin's mechanical properties (e.g. elasticity and stiffness). The device will provide a digital readout that will be averaged to obtain a mean value.	90 days post-grafting
Biomechanics Stiffness	Biomechanics Stiffness 10-12 months post grafting: The BTC-2000 device uses a laser to measure skin deflection as negative atmospheric pressure is applied and this allows for quantification of the skin's mechanical properties (e.g. elasticity and stiffness). The device will provide a digital readout that will be averaged to obtain a mean value.	1 year post-grafting
Biomechanics Elasticity	Elasticity will be quantified using a BTC-2000, a high resolution Target Laser and negative pressure transducer. The BTC-2000 device uses a laser to measure skin deflection as negative atmospheric pressure is applied and this allows for quantification of the skin's mechanical properties (e.g. elasticity and stiffness). The device will provide a digital readout that will be averaged to obtain a mean value.	90 days post-grafting
Biomechanics Elasticity	Elasticity will be quantified using a BTC-2000, a high resolution Target Laser and negative pressure transducer. The BTC-2000 device uses a laser to measure skin deflection as negative atmospheric pressure is applied and this allows for quantification of the skin's mechanical properties (e.g. elasticity and stiffness). The device will provide a digital readout that will be averaged to obtain a mean value.	1 year post-grafting
Vancouver Scar Scale (VSS)	Scar-rating scale that objectively evaluates scar properties to include the following: Vascularity: Normal = 0, Pink=1, Red = 2, Purple = 3; Pigmentation: Normal= 0, Hypopigmentation= 1, Hyperpigmentation= 2; Pliability: Normal= 0, Supple =1, Yielding= 2, Firm= 3, Ropes= 4, Contracture= 5; Height: Flat= 0, <2mm=1, 2-5mm=2, >5mm=3; Lowest possible score= 0 and Highest Score possible = 13. Higher results denotes worse outcomes.	90 days post-grafting
Vancouver Scar Scale (VSS)	Scar-rating scale that objectively evaluates scar properties to include the following: Vascularity: Normal = 0, Pink=1, Red = 2, Purple = 3; Pigmentation: Normal= 0, Hypopigmentation= 1, Hyperpigmentation= 2; Pliability: Normal= 0, Supple =1, Yielding= 2, Firm= 3, Ropes= 4, Contracture= 5; Height: Flat= 0, <2mm=1, 2-5mm=2, >5mm=3; Lowest possible score= 0 and Highest Score possible = 13. Higher results denotes worse outcomes.	1 year post-grafting
Patient-Reported Satisfaction	Subjective measurement of patient satisfaction of outcome based on a 0-10 Likert scale with 10 being the best outcome.	90 days post-grafting
Patient-Reported Satisfaction	Subjective measurement of patient satisfaction of outcome based on a 0-10 Likert scale with 10 being the best outcome.	1 year post-grafting
Erythema Index	Erythema will be measured using a Mexameter that will accurately measure even small changes in erythema levels, then provide a digital read out from which an average mean can be obtained. The erythema levels are measured on a scale ranging from 0 to around 999. This index reflects the redness of the skin, which can be an indicator of various skin conditions or reactions. Higher index indicates a scar that is more red.	90 days post-grafting
Erythema Index	Erythema will be measured using a Mexameter that will accurately measure even small changes in erythema levels, then provide a digital read out from which an average mean can be obtained. The erythema levels are measured on a scale ranging from 0 to around 999. This index reflects the redness of the skin, which can be an indicator of various skin conditions or reactions. Higher index indicates a scar that is more red.	1 year post-grafting
Patient and Observer Scar Assessment Scale (POSAS)--Patient	Subjective scar scale for the patient that measures perception of scar height, pliability, pigmentation, vascularization, and relief. Survey consists of seven questions with total score ranging from 7-70. The higher the score the worse the scar.	90 days post-grafting
Patient and Observer Scar Assessment Scale (POSAS)--Observer	Subjective scar scale for the observer measures perception of scar height, pliability, pigmentation, vascularization, and relief. Survey consists of six questions. Total score range 6-60. The higher the score the worse the scar.	90 days post-grafting
Patient and Observer Scar Assessment Scale (POSAS)--Patient	Subjective scar scale for the patient that measures perception of scar height, pliability, pigmentation, vascularization, and relief. Survey consists of seven questions with total score ranging from 7-70. The higher the score the worse the scar.	1 year post-grafting
Patient and Observer Scar Assessment Scale (POSAS)--Observer	Subjective scar scale for the observer measures perception of scar height, pliability, pigmentation, vascularization, and relief. Survey consists of six questions. Total score range 6-60. The higher the score the worse the scar.	1 year post-grafting

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: John Bailey, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): September 29, 2023

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Fractional laser; Ablative Laser; Carbon Dioxide Laser
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Lidocaine; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: IRB00058363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will plan to share individual participant data with other researchers. We welcome critical examination of the protocol, statistical analysis of recorded data, informed consent form, and clinical study report. We are happy to share de-identified data (original photo files, tracings, and recorded measures of skin quality) and responses to questionnaires.
• IPD Sharing Time Frame: Data will become available within 6 months of data completion.
• IPD Sharing Access Criteria: Research groups with authors who have at least one related publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes