CO2 Laser Phototherapy for Management of Mature Burn Scars

Study Overview
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Brief Summary
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Evaluate mature burn scars before and after treatment with CO2 for patients age 3-21 while comparing the treated areas to an untreated control area in the same patient.

Detailed Description
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Laser phototherapy has gained growing acceptance and popularity for management of burn scars. The most commonly used laser is the Carbon Dioxide (CO2) Laser. At this institution, the investigator has used CO2 for management of Burn Scars since 2012. While the existing literature and the investigator's anecdotal experience thus far has been positive overall, there is no conclusive evidence to support that CO2 does indeed improve the quality of mature burn scars The primary objective of this study is to evaluate mature burn scars before and after treatment with CO2 for patients age 3-21 while comparing the treated areas to an untreated control area in the same patient.

Official Title
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Randomized, Prospective, Split Scar Pilot Study to Evaluate the Efficacy of CO2 Laser Phototherapy for Management of Mature Burn Scars

Conditions
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Burn Scar

Intervention / Treatment
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* Procedure: Laser phototherapy treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 3 to 21 Patients with mature burn scars that are at least two years old from burn injury and that have not previously undergone CO2 laser therapy for scar revision. Scars in all body areas with the exception of face, genitals or hands will be considered eligible for the study Entry into this study is open to pediatric patients of both genders. Entry into this study is open to pediatric patients of all ethnic backgrounds. Entry into this study is open to females of childbearing potential with a negative urine or serum pregnancy test Exclusion Criteria: Patients with scars less than 2 years old Patients with contraindications to laser treatment (i.e.: active acne infections/ treatment with isotretinoin, active Zoster infection) Patients receiving other forms of scar revision therapy such as other laser types, steroid injections, or surgical excisions.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 21 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
Interventional Model Description: The study patient will have one portion of their scar, measuring 5x5 cms (or 50% of the scar, for scars smaller than 5x10 cms) left untreated at the time of the study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No laser phototherapy treatment | |
| Experimental: Laser phototherapy treatment<br>Laser phototherapy treatment administered in OR | Procedure: Laser phototherapy treatment<br>* Laser phototherapy treatment administered in OR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scar assessment evaluation | Patient and Observer Scar Assessment Scale | Prior to initial treatment and no sooner than 3 months following last treatment |