Fractional Ablative Laser Treatment for Skin Grafts

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Burn Scar, Skin Graft Scar

Intervention / Treatment
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* Drug: Lidocaine Cream
* Drug: Triamcinolone Acetonide Cream
* Device: Fractional Ablative Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are to undergo skin grafting procedures for acture 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser<br> | Drug: Lidocaine Cream<br>* 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.<br>Drug: Triamcinolone Acetonide Cream<br>* 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.<br>Device: Fractional Ablative Laser<br>* Applied to only site that is randomized to laser intervention<br>|
| Placebo Comparator: No laser<br> | Drug: Lidocaine Cream<br>* 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.<br>Drug: Triamcinolone Acetonide Cream<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contracture of Scar Surface 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 | 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 | 
| Erythema | 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. | 90 days post-grafting | 
| Erythema | 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. | 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 and Observer Scar Assessment Scale (POSAS)--Patient | Subjective scar scale for the patient that measures perception of scar height, pliability, pigmentation, vascularization, and relief. Scores ranging from 1 meaning no complaint to 10 meaning worst scar imaginable for the patient assessment. | 90 days post-grafting | 
| Patient and Observer Scar Assessment Scale (POSAS)--Observer | Subjective scar scale for the observer that measures perception of scar height, pliability, pigmentation, vascularization, and relief. For the observer assessment, score ranges from 1-10 with one indicating normal skin and ten indicating the worst scar imaginable. | 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. Scores ranging from 1 meaning no complaint to 10 meaning worst scar imaginable for the patient assessment. | 1 year post-grafting | 
| Patient and Observer Scar Assessment Scale (POSAS)--Observer | Subjective scar scale for the observer that measures perception of scar height, pliability, pigmentation, vascularization, and relief. For the observer assessment, score ranges from 1-10 with one indicating normal skin and ten indicating the worst scar imaginable. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fractional laser, Ablative Laser, Carbon Dioxide Laser