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

Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02472405
• Other study ID #: 20140348
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: November 2017

Study information

• Verified date: July 2018
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Scar

Intervention

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

Locations

Country	Name	City	State
United States	University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	2 months