Fractional Ablative Laser Treatment for Skin Grafts
- Conditions
- Skin Graft ScarBurn Scar
- Interventions
- Registration Number
- NCT04176705
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- Patients who are to undergo skin grafting procedures for acute treatment of thermal burns.
- Patients with grafts placed over at least 100cm^2
- Patients who have are not scheduled to undergo skin grafting procedures
- Patients who have grafts placed under 100cm^2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No laser Triamcinolone Acetonide Cream 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. No laser Lidocaine Cream 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. Laser Triamcinolone Acetonide Cream 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. Laser Lidocaine Cream 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. Laser Fractional Ablative 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.
- Primary Outcome Measures
Name Time Method Contracture of Scar Surface Area (Percentage of Original Area) 1 year post-grafting 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.
- Secondary Outcome Measures
Name Time Method Scar Roughness 1 year post-grafting 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.
Biomechanics Stiffness 1 year post-grafting 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.
Biomechanics Elasticity 1 year post-grafting 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.
Erythema Index 1 year post-grafting 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.
Vancouver Scar Scale (VSS) 1 year post-grafting 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.
Patient and Observer Scar Assessment Scale (POSAS)--Patient 1 year post-grafting 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.
Patient and Observer Scar Assessment Scale (POSAS)--Observer 1 year post-grafting 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.
Patient-Reported Satisfaction 1 year post-grafting Subjective measurement of patient satisfaction of outcome based on a 0-10 Likert scale with 10 being the best outcome.
Trial Locations
- Locations (1)
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States