Fractionated Carbon Dioxide Laser and Burn Scar Contractures: Evaluation of Post-Treatment Scar Function and Appearance
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|ClinicalTrials.gov Identifier: NCT02115646|
Recruitment Status : Completed
First Posted : April 16, 2014
Results First Posted : May 15, 2018
Last Update Posted : June 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Burn Scars||Device: fractionated carbon dioxide laser||Not Applicable|
The primary goal of the study will analyze whether the fractionated carbon dioxide laser can improve other subjective and objective qualities of hypertrophic and/or contracted burn scars with or without involvement of nearby mobile joints.
The investigators hypothesize that fractionated carbon dioxide laser therapy will increase range of motion and improve tissue compliance in all scars overlying a mobile joint that has been limited due to burn scar contracture. In addition, the investigators will evaluate the effect of fractionated carbon dioxide laser therapy on common sequelae of hypertrophic and/or contracted burn scars.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fractionated Carbon Dioxide Laser and Burn Scar Contractures: Evaluation of Post-Treatment Scar Function and Appearance|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Experimental: fractionated carbon dioxide laser
fractionated carbon dioxide laser
Device: fractionated carbon dioxide laser
patients will have serial laser treatments
Other Name: UltraPulse, Lumenis
- Scar Pigmentation, Baseline vs 15-months [ Time Frame: Baseline and 15 months ]Using the colorimeter, will measure change in pigmentation of the scar at the conclusion of the study. This tool measures the pigment in a scar, with a possible range of 0-100, with 100 being the darkest hyperpigmentation, and 0 being no hyperpigmentation.
- Scar Elasticity, Baseline vs 15-months [ Time Frame: Baseline and 15 months ]This is the measure of the elasticity of the scar using a Torque-meter. It is measured on a 0-1 unit scale, with 0 being normal skin elasticity and 1 being completely inelastic.
- Scar Thickness [ Time Frame: Baseline and 15 months ]This is an ultrasound measurement using the Dermascan Cyberderm to measure the thickness of the scar at baseline in millimeters.
- Quality of Life [ Time Frame: Baseline and 15 months ]The 36-Item Short Form Survey (SF-36) is a validated quality of life measurement tool. It measures 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. It is scored on a 0-100 scale, with 100 being the least bothersome to quality of life.
- POSAS [ Time Frame: Baseline and 15 months ]The Patient and Observer Scar Assessment Scale (POSAS) is a validated scale that measures both the patient assessment and the observer assessment on the quality (height, color, stiffness, thickness, symptoms, relief, surface area) of the scar. Scores range from 0-60, with 60 being the worst quality of scar.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115646
|United States, Massachusetts|
|Shriners Hospital- Boston|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Richard R Anderson, MD||Massachusetts General Hospital|