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

Sponsor:

Collaborators:

Shriners Hospitals for Children

United States Department of Defense

Information provided by (Responsible Party):

Richard Rox Anderson, MD, Massachusetts General Hospital

Study Type	Interventional
Study Design	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Burn Scars
Intervention	Device: fractionated carbon dioxide laser
Enrollment	29

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Fractionated CO2 Laser Treatment
Arm/Group Description	Fractionated carbon dioxide laser ...
Arm/Group Description	Fractionated carbon dioxide laser Fractionated carbon dioxide laser: patients received serial fractionated CO2 laser treatments for a total fo 3 treatments.
Period Title: Overall Study
Started	29
Completed	22
Not Completed	7

Baseline Characteristics

Arm/Group Title		Fractionated CO2 Laser Treatment
Arm/Group Description		Fractionated carbon dioxide laser ...
Arm/Group Description		Fractionated carbon dioxide laser Fractionated carbon dioxide laser: patients received serial fractionated CO2 laser treatments for a total fo 3 treatments.
Overall Number of Baseline Participants		22
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Subjects with hypertrophic burn scars.
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	22 participants
	<=18 years	11 50.0%
	Between 18 and 65 years	11 50.0%
	>=65 years	0 0.0%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	22 participants
		28 (16.8)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	22 participants
	Female	7 31.8%
	Male	15 68.2%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	22 participants
	Hispanic or Latino	5 22.7%
	Not Hispanic or Latino	16 72.7%
	Unknown or Not Reported	1 4.5%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	22 participants
	American Indian or Alaska Native	0 0.0%
	Asian	1 4.5%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	1 4.5%
	White	20 90.9%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants
United States	Number Analyzed	22 participants
United States		22 100.0%
Scar pigmentation ^[1] Mean (Full Range) Unit of measure: Units on a scale
	Number Analyzed	22 participants
		50.93 (13 to 88)
		[1] Measure Description: This is a measurement of the pigmentation of the scar using a colorimeter device. The scale is rated using a range of 0-100 units, with 100 being the deepest hyperpigmentation, and 0 being no hyperpigmentation.
Scar elasticity ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	Number Analyzed	22 participants
		0.65 (0.12)
		[1] Measure Description: 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 ^[1] Mean (Standard Deviation) Unit of measure: Mm
	Number Analyzed	22 participants
		3.28 (1.21)
		[1] Measure Description: This is an ultrasound measurement using the Dermascan Cyberderm to measure the thickness of the scar at baseline in millimeters.
Quality of Life ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	Number Analyzed	22 participants
		91.25 (8.56)
		[1] Measure Description: 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 ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	Number Analyzed	22 participants
		27.2 (1.8)
		[1] Measure Description: 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.

Outcome Measures

1.Primary Outcome


Title	Scar Pigmentation, Baseline vs 15-months
Description	Using the colorimeter, will measure change in pigmentation of the scar...
Description	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.
Time Frame	Baseline and 15 months

Outcome Measure Data

Analysis Population Description