NCT02472405

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

Comparing the 595/1064nm Multiplex Laser to the 595nm PDL in the Treatment of Surgical Scars in a Blinded, Randomized, Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Scar

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	595nm PDL	One third of the scar will be treated with 595nm PDL solely for 3 weeks (1 treatment session per week).

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-11-01
• Completion: 2017-11-01
• First posted: 2015-06-15
• Last updated: 2018-08-21
• Results posted: 2018-08-21

Locations

1 site across 1 country: United States