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

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.

Study Overview

• Status: Completed
• Conditions: Scar
• Intervention / Treatment: Device: 595nm PDL; Device: 595/1064nm Multiplex Laser

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Sylvester Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 595nm PDL; 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.	Device: 595nm PDL; One third of the scar will be treated with 595nm PDL solely for 3 weeks (1 treatment session per week).
Active Comparator: 595/1064nm Multiplex Laser; 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.	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.
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Keyvan Nouri, MD, University of Miami Sylvester Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: March 2, 2015
• First Submitted That Met QC Criteria: June 11, 2015
• First Posted (Estimate): June 15, 2015

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 20140348