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Trial record 20 of 1688 for:    CARBON DIOXIDE AND dioxide

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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fractionated CO2 Laser Treatment
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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
Arm/Group Title Fractionated CO2 Laser Treatment
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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
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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
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.
1.Primary Outcome
Title Scar Pigmentation, Baseline vs 15-months
Hide 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
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Hide Analysis Population Description
All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated.
Arm/Group Title Baseline 15-months
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Characteristics of study population at baseline.
Characteristics of study population at conclusion of study.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
50.93  (4.3) 49.59  (4.1)
2.Primary Outcome
Title Scar Elasticity, Baseline vs 15-months
Hide 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.
Time Frame Baseline and 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated.
Arm/Group Title Baseline 15-months
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Characteristics of study population at baseline
Characteristics of study population at conclusion of study
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.65  (0.12) 0.49  (0.10)
3.Primary Outcome
Title Scar Thickness
Hide Description This is an ultrasound measurement using the Dermascan Cyberderm to measure the thickness of the scar at baseline in millimeters.
Time Frame Baseline and 15 months
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Hide Analysis Population Description
All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated.
Arm/Group Title Baseline 15-months
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Characteristics of study population at baseline.
Characteristics of study population at 15-months
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: mm
3.28  (1.21) 2.58  (1.01)
4.Secondary Outcome
Title Quality of Life
Hide 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.
Time Frame Baseline and 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated.
Arm/Group Title Baseline 15-months
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Characteristics of study population at baseline
Characteristics of study population at conclusion of study
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
91.25  (8.56) 97.22  (3.70)
5.Secondary Outcome
Title POSAS
Hide 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.
Time Frame Baseline and 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated.
Arm/Group Title Baseline 15-months
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Characteristics of study population at baseline.
Characteristics of study population at 15-months.
Overall Number of Participants Analyzed 22 22
Mean (Standard Error)
Unit of Measure: units on a scale
27.2  (1.8) 15.8  (2.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fractionated CO2 Laser Treatment
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Fractionated carbon dioxide laser

Fractionated carbon dioxide laser: patients received serial fractionated CO2 laser treatments for a total fo 3 treatments.

All-Cause Mortality
Fractionated CO2 Laser Treatment
Affected / at Risk (%)
Total   0/22 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Fractionated CO2 Laser Treatment
Affected / at Risk (%)
Total   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fractionated CO2 Laser Treatment
Affected / at Risk (%)
Total   0/22 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kachiu Lee, MD
Organization: MGH Wellman Center
Phone: 4018303128
EMail: klee52@partners.org
Layout table for additonal information
Responsible Party: Richard Rox Anderson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02115646     History of Changes
Other Study ID Numbers: 2011P001310
First Submitted: July 1, 2013
First Posted: April 16, 2014
Results First Submitted: January 8, 2018
Results First Posted: May 15, 2018
Last Update Posted: June 26, 2018