CO2 Laser Phototherapy for Management of Mature Burn Scars

Not Applicable

Completed

• Conditions: Burn Scar
• Interventions: Procedure: Laser phototherapy treatment

• Registration Number: NCT03197649
• Lead Sponsor: University of California, Davis

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-05-22
• Study First Submitted: 2017-06-14
• Study First Submitted QC: 2017-06-21
• Study First Posted: 2017-06-23
• Primary Completion: 2019-04-29
• Study Completion: 2019-04-29
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser phototherapy treatment	Laser phototherapy treatment	Laser phototherapy treatment administered in OR

Primary Outcome Measures

Name	Time	Method
Change in scar assessment evaluation	Prior to initial treatment and no sooner than 3 months following last treatment	Patient and Observer Scar Assessment Scale

Trial Locations

Locations (1)

Shriners Hospitals for Children; 🇺🇸 Sacramento, California, United States