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This study aims to determine if the 595nm Pulsed dye laser, the combined 595/1064nm Multiplex laser or no treatment results in a better outcome in the quality of the surgical scar using the multiplex cynergy laser, starting treatment the day of suture removal.
This study aims to determine if the 595nm Pulsed dye laser, the combined 595/1064nm Multiplex laser or no treatment results in a better outcome in the quality of the surgical scar using the multiplex cynergy laser, starting treatment the day of suture removal.
Patients will be offered the opportunity of enrolling in the trial before their surgery. If they qualify and agree to participate they will sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) form.
The surgical defect should be closed primarily, with the minimal scar length being 3cm. The scar will be randomized into 3 equal thirds, each third will randomly receive either: no treatment, 595nm PDL, or 595/1064nm Multiplex laser. A total of 3 laser treatments will be performed over a period of 3 weeks (one treatment session performed every week), and the patient will come in for a final follow up visit, for a final assessment of the scar using the Patient and Observer Scar Assessment Scale (POSAS) system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 595nm PDL | Active Comparator | One third of the scar will be treated with 595nm PDL solely for 3 weeks (1 treatment session per week). A blinded observer will evaluate each third of the scar 4 weeks after the last treatment session using the POSAS system. |
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| 595/1064nm Multiplex Laser | Active Comparator | One third of the scar will be treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). A blinded observer will evaluate each third of the scar 4 weeks after the last treatment session using the POSAS system. |
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| Control | No Intervention | One third of the scar will be left untreated for the duration of the study. A blinded observer will evaluate each third of the scar 4 weeks after the last treatment session using the POSAS system. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 595/1064nm Multiplex Laser | Device | The multiplex cynergy laser will be used for this study. A third of the scar will solely be treated with the 595nm PDL. |
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| Measure | Description | Time Frame |
|---|---|---|
| POSAS (The Patient and Observer Scar Assessment Scale) Measure | POSAS is a scale that contains the following parameters: pigmentation, vascularity, pliability, height, surface area, and patient input with regards to pain, itching, relief, stiffness, color and thickness. Both the patient and the observer are asked to give their Overall Opinion on the appearance of the scar. Again, a 10-point scale (ranging from 1 to 10) is used in which 10 corresponds to the worst imaginable scar. | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keyvan Nouri, MD | University of Miami Sylvester Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 595nm PDL - 595/1064nm Multiplex - Control | A third of each participant's scar was treated with 595nm PDL solely for 3 weeks (1 treatment session per week). Another third of the scar was treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). And the remaining third of the scar was left untreated for the duration of the study. The order of treatment was not randomized. A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 595nm PDL - 595/1064nm Multiplex - Control | A third of each participant's scar was treated with 595nm PDL solely for 3 weeks (1 treatment session per week). Another third of the scar was treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). And the remaining third of the scar was left untreated for the duration of the study. The order of treatment was not randomized. A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system. |
| 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 | POSAS (The Patient and Observer Scar Assessment Scale) Measure | POSAS is a scale that contains the following parameters: pigmentation, vascularity, pliability, height, surface area, and patient input with regards to pain, itching, relief, stiffness, color and thickness. Both the patient and the observer are asked to give their Overall Opinion on the appearance of the scar. Again, a 10-point scale (ranging from 1 to 10) is used in which 10 corresponds to the worst imaginable scar. | The measurement used for this outcome was completed 4 weeks post final intervention, only eight participants completed the study protocol, but only 6 participant's POSAS score was collected. Observer's score for the POSAS is not available. Only the score for the participants was reported. | Posted | Mean | Standard Deviation | Score | 2 months |
|
Seven weeks.
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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 | 595nm PDL - 595/1064nm Multiplex Laser - Control | A third of each participant's scar was treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). Another third of the scar was treated with 595nm PDL solely for 3 weeks (1 treatment session per week). The remaining third of the scar was left untreated for the duration of the study. A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system. 595/1064nm Multiplex Laser: The multiplex cynergy laser will be used for this study. A third of the scar will solely be treated with the 595nm PDL. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor bleeding and scabbing | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keyvan Nouri MD | University of Miami | 305-243-3380 | KNouri@med.miami.edu |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Each participant scar was randomized to the 3 treatment arms.
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| 595nm PDL | Device | One third of the scar will be treated with 595nm PDL solely for 3 weeks (1 treatment session per week). |
|
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | 595/1064nm Multiplex Laser | One third of the scar was treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system. 595/1064nm Multiplex Laser: The multiplex cynergy laser was used for this study. A third of the scar was solely be treated with the 595nm PDL. |
| OG002 | Control | One third of the scar was left untreated for the duration of the study. A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system. |
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 2 |
| 18 |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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