Back to resultsCO2 Laser Phototherapy for Management of Mature Burn Scars
Primary Purpose
Burn Scar
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laser phototherapy treatment
Sponsored by
About this trial
This is an interventional treatment trial for Burn Scar
Eligibility Criteria
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.
Sites / Locations
- Shriners Hospitals for Children
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Laser phototherapy treatment
Arm Description
No laser phototherapy treatment
Laser phototherapy treatment administered in OR
Outcomes
Primary Outcome Measures
Change in scar assessment evaluation
Patient and Observer Scar Assessment Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT03197649
First Posted
June 14, 2017
Last Updated
July 14, 2020
Sponsor
University of California, Davis
Collaborators
Shriners Hospitals for Children
1. Study Identification
Unique Protocol Identification Number
NCT03197649
Brief Title
CO2 Laser Phototherapy for Management of Mature Burn Scars
Official Title
Randomized, Prospective, Split Scar Pilot Study to Evaluate the Efficacy of CO2 Laser Phototherapy for Management of Mature Burn Scars
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
April 29, 2019 (Actual)
Study Completion Date
April 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Shriners Hospitals for Children
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Scar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Participant is blinded
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No laser phototherapy treatment
Arm Title
Laser phototherapy treatment
Arm Type
Experimental
Arm Description
Laser phototherapy treatment administered in OR
Intervention Type
Procedure
Intervention Name(s)
Laser phototherapy treatment
Intervention Description
Laser phototherapy treatment administered in OR
Primary Outcome Measure Information:
Title
Change in scar assessment evaluation
Description
Patient and Observer Scar Assessment Scale
Time Frame
Prior to initial treatment and no sooner than 3 months following last treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pirko Maguina, MD
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Hospitals for Children
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan
Learn more about this trial
CO2 Laser Phototherapy for Management of Mature Burn Scars
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