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

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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

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.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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