Scar
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICE595/1064nm 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.
DEVICE595nm PDL
One third of the scar will be treated with 595nm PDL solely for 3 weeks (1 treatment session per week).
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Each participant scar was randomized to the 3 treatment arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Fitzpatrick skin types 1-3 * Suture line should be at least 3 cm long
Exclusion criteria
* The patient should not be receiving any alternate systemic, topical or intralesional treatment of the scars during the study * Pregnant or lactating females * Fitzpatrick skin type 4-6 * A history of keloids or hypertrophic scars
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| POSAS (The Patient and Observer Scar Assessment Scale) Measure | 2 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 9 |
Baseline characteristics
| Characteristic | 595nm PDL - 595/1064nm Multiplex - Control | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 7 Participants | — |
| Age, Categorical Between 18 and 65 years | 11 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 2 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
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.
Time frame: 2 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 595nm PDL | POSAS (The Patient and Observer Scar Assessment Scale) Measure | 2.5 Score | Standard Deviation 1.5 |
| 595/1064nm Multiplex Laser | POSAS (The Patient and Observer Scar Assessment Scale) Measure | 2.5 Score | Standard Deviation 1.5 |
| Control | POSAS (The Patient and Observer Scar Assessment Scale) Measure | 2.5 Score | Standard Deviation 1.5 |