Multiplex Laser vs. PDL (Pulsed Dye Laser ) in the Treatment of Surgical Scars

University of Miami

Status: Completed

Conditions: Scar

Treatments: Device: 595/1064nm Multiplex Laser; Device: 595nm PDL

Study type: Interventional

Funder types: Other

Identifiers

NCT02472405

20140348

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 3 patient groups

595nm PDL

Active Comparator group

Description:

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.

Treatment:

Device: 595nm PDL

595/1064nm Multiplex Laser

Active Comparator group

Description:

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.

Treatment:

Device: 595/1064nm Multiplex Laser

Control

No Intervention group

Description:

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.