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| Name | Class |
|---|---|
| Shriners Hospitals for Children | OTHER |
| United States Department of Defense | FED |
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The investigators are studying the appearance and function of burn scars after treatment with fractionated carbon dioxide laser. The investigators hypothesize that the cosmetic appearance and range of motion will improve with treatment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fractionated carbon dioxide laser | Experimental | fractionated carbon dioxide laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fractionated carbon dioxide laser | Device | patients will have serial laser treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Scar Pigmentation, Baseline vs 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. | Baseline and 15 months |
| Scar Elasticity, Baseline vs 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. | Baseline and 15 months |
| Scar Thickness | This is an ultrasound measurement using the Dermascan Cyberderm to measure the thickness of the scar at baseline in millimeters. | Baseline and 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard R Anderson, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shriners Hospital- Boston | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31469749 | Derived | Miletta N, Siwy K, Hivnor C, Clark J, Shofner J, Zurakowski D, Anderson RR, Lee K, Donelan M. Fractional Ablative Laser Therapy is an Effective Treatment for Hypertrophic Burn Scars: A Prospective Study of Objective and Subjective Outcomes. Ann Surg. 2021 Dec 1;274(6):e574-e580. doi: 10.1097/SLA.0000000000003576. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects with hypertrophic burn scars.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Scar Pigmentation, Baseline vs 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. | All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 15 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kachiu Lee, MD | MGH Wellman Center | 4018303128 | klee52@partners.org |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Baseline and 15 months |
| POSAS | 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. | Baseline and 15 months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Scar pigmentation | 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. | Mean | Full Range | units on a scale |
|
| Scar elasticity | 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. | Mean | Standard Deviation | units on a scale |
|
| Scar thickness | This is an ultrasound measurement using the Dermascan Cyberderm to measure the thickness of the scar at baseline in millimeters. | Mean | Standard Deviation | mm |
|
| Quality of Life | 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. | Mean | Standard Deviation | units on a scale |
|
| POSAS | 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. | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Scar Elasticity, Baseline vs 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. | All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 15 months |
|
|
|
| Primary | Scar Thickness | This is an ultrasound measurement using the Dermascan Cyberderm to measure the thickness of the scar at baseline in millimeters. | All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated. | Posted | Mean | Standard Deviation | mm | Baseline and 15 months |
|
|
|
| Secondary | Quality of Life | 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. | All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 15 months |
|
|
|
| Secondary | POSAS | 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. | All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated. | Posted | Mean | Standard Error | units on a scale | Baseline and 15 months |
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