Fractional Photothermolysis for the Treatment of Burn Scars

Study Overview
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Brief Summary
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The aim of our study is to determine the effect of fractional photothermolysis laser in the treatment of burn scars.

Detailed Description
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One of the main problems in the management of burned patients is the treatment of post-burn scarring. Frequently this scars cover large areas, tend to retract, present pigmentary changes and are disfiguring, producing significant life quality impairment. Unfortunately, there are very few therapeutic options for treating these scars, which can be secondary to reconstructive surgery or after spontaneous healing. In the last decades most reports in scar treatment have included, pressure garments, chemical peeling, dermabrasion, ablative and non-ablative laser therapy and surgery with varying degrees of success. There is only one report treating burn scars with fractional laser, with good results. The aim of our study is to determine the effect of of a second-generation erbium-doped 1,550-nm fractional photothermolysis laser (Fraxel SR laser, Reliant Technologies Inc.) in the treatment of burn scars.

Official Title
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Fractional Photothermolysis for the Treatment of Burn Scars

Conditions
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Scar

Intervention / Treatment
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* Procedure: Fractional laser treatment
* Procedure: Standard scar management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Burn scars should be located on the anterior thorax or abdomen with at least 4 months of evolution. The scar should be slightly elevated, with erythema and with no signs of keloid formation. Maximum scar dimension: 0.2 - 1% body surface area. Acceptance of informed consent for laser treatment. Exclusion Criteria: Previous non-surgical treatment (i.e. dermabrasion, laser, peelings, bleaching agent. etc). Previous surgical treatment (i.e. graft)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser treated scar<br>The standard treated scar arm consists of a similar lesion in an equivalent location in the same patient or the half of a lesion that is suitable to be divided (size at least 4% body surface area). This arm will be managed only with standard burn treatment modalities. | Procedure: Fractional laser treatment<br>* A complete treatment will consist in four laser sessions with a second-generation erbium-doped 1,550-nm fractional photothermolysis laser (Fraxel SR laser, Reliant Technologies Inc at 1-month intervals. Treatment will be delivered with a 15-mm tip and concomitant air-cooling system (Zimmer MedizinSystems, Irvine, CA). Fluence and treatment level will be registered on every session and will be adjusted according to patient tolerance.<br>|
| Active Comparator: Standard scar management<br>The standard scar management arm consists of a similar lesion in an equivalent location in the same patient or the half of a lesion that is suitable to be divided (size at least 4% body surface area). This arm will be managed only with standard burn treatment modalities. | Procedure: Standard scar management<br>* The standard treated scar arm consists of a similar lesion in an equivalent location in the same patient or the half of a lesion that is suitable to be divided (size at least 4% body surface area). This arm will be managed only with standard burn treatment modalities.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of improvement in color and texture of burn scars, using digital colorimeter and digital photography. |  | 5 months | 
| Adverse effects: pain, erythema, edema, hypopigmentation, hyperpigmentation, hypertrophic scar and keloid formation |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in surface area and perimeter of burn scar |  | 5 months | 
| Tissue pliability, elevation and flexibility with a digital piedemeter |  | 5 months | 
| Change in collagen fiber organization and blood vessel density with a reflectance laser confocal microscope. |  | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scars secondary to injuries to tissues caused by contact with physical (heat, electricity) o chemical agent.