A Phase 1 interventional study of Fractional laser treatment and Standard scar management in Scar, sponsored by Clinica las Condes, Chile. Status unknown at 1 site in Chile. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2009-11-01.
Sponsored by Clinica las Condes, Chile · Phase 1, Interventional, and Treatment
The aim of our study is to determine the effect of fractional photothermolysis laser in the treatment of burn scars.
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.
306 studies on the registry are indexed under Cicatrix; 50 are open to participants now.
This study's planned enrollment of 10 is below the median of 39 across 250 interventional studies indexed under Cicatrix.
Browse Cicatrix studies →Clinica las Condes, Chile is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
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
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.
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.
Evidence of improvement in color and texture of burn scars, using digital colorimeter and digital photography.
Time frame: 5 months
Adverse effects: pain, erythema, edema, hypopigmentation, hyperpigmentation, hypertrophic scar and keloid formation
Time frame: 5 months
Change in surface area and perimeter of burn scar
Time frame: 5 months
Tissue pliability, elevation and flexibility with a digital piedemeter
Time frame: 5 months
Change in collagen fiber organization and blood vessel density with a reflectance laser confocal microscope.
Time frame: 5 months
This study is status unknown, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.
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Clinica las Condes, Chile