Trial Outcomes & Findings for Fractionated Carbon Dioxide Laser and Burn Scar Contractures: Evaluation of Post-Treatment Scar Function and Appearance (NCT NCT02115646)
NCT ID: NCT02115646
Last Updated: 2018-06-26
Results Overview
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.
COMPLETED
NA
29 participants
Baseline and 15 months
2018-06-26
Participant Flow
Participant milestones
| Measure |
Fractionated CO2 Laser Treatment
Fractionated carbon dioxide laser
Fractionated carbon dioxide laser: patients received serial fractionated CO2 laser treatments for a total fo 3 treatments.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fractionated Carbon Dioxide Laser and Burn Scar Contractures: Evaluation of Post-Treatment Scar Function and Appearance
Baseline characteristics by cohort
| Measure |
Fractionated CO2 Laser Treatment
n=22 Participants
Fractionated carbon dioxide laser
Fractionated carbon dioxide laser: patients received serial fractionated CO2 laser treatments for a total fo 3 treatments.
|
|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
28 years
STANDARD_DEVIATION 16.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
|
Scar pigmentation
|
50.93 units on a scale
n=5 Participants
|
|
Scar elasticity
|
0.65 units on a scale
STANDARD_DEVIATION 0.12 • n=5 Participants
|
|
Scar thickness
|
3.28 mm
STANDARD_DEVIATION 1.21 • n=5 Participants
|
|
Quality of Life
|
91.25 units on a scale
STANDARD_DEVIATION 8.56 • n=5 Participants
|
|
POSAS
|
27.2 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 15 monthsPopulation: All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated.
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.
Outcome measures
| Measure |
Baseline
n=22 Participants
Characteristics of study population at baseline.
|
15-months
n=22 Participants
Characteristics of study population at conclusion of study.
|
|---|---|---|
|
Scar Pigmentation, Baseline vs 15-months
|
50.93 units on a scale
Standard Deviation 4.3
|
49.59 units on a scale
Standard Deviation 4.1
|
PRIMARY outcome
Timeframe: Baseline and 15 monthsPopulation: All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated.
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.
Outcome measures
| Measure |
Baseline
n=22 Participants
Characteristics of study population at baseline.
|
15-months
n=22 Participants
Characteristics of study population at conclusion of study.
|
|---|---|---|
|
Scar Elasticity, Baseline vs 15-months
|
0.65 units on a scale
Standard Deviation 0.12
|
0.49 units on a scale
Standard Deviation 0.10
|
PRIMARY outcome
Timeframe: Baseline and 15 monthsPopulation: All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated.
This is an ultrasound measurement using the Dermascan Cyberderm to measure the thickness of the scar at baseline in millimeters.
Outcome measures
| Measure |
Baseline
n=22 Participants
Characteristics of study population at baseline.
|
15-months
n=22 Participants
Characteristics of study population at conclusion of study.
|
|---|---|---|
|
Scar Thickness
|
3.28 mm
Standard Deviation 1.21
|
2.58 mm
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Baseline and 15 monthsPopulation: All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated.
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.
Outcome measures
| Measure |
Baseline
n=22 Participants
Characteristics of study population at baseline.
|
15-months
n=22 Participants
Characteristics of study population at conclusion of study.
|
|---|---|---|
|
Quality of Life
|
91.25 units on a scale
Standard Deviation 8.56
|
97.22 units on a scale
Standard Deviation 3.70
|
SECONDARY outcome
Timeframe: Baseline and 15 monthsPopulation: All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated.
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
| Measure |
Baseline
n=22 Participants
Characteristics of study population at baseline.
|
15-months
n=22 Participants
Characteristics of study population at conclusion of study.
|
|---|---|---|
|
POSAS
|
27.2 units on a scale
Standard Error 1.8
|
15.8 units on a scale
Standard Error 2.4
|
Adverse Events
Fractionated CO2 Laser Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place