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

NCT02472405 | Completed Results DMC

• 1 other identifier: 20140348
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Scar

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

595nm PDL

ACTIVE COMPARATOR

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

595/1064nm Multiplex Laser

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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.

Interventions

595/1064nm Multiplex Laser DEVICE

The multiplex cynergy laser will be used for this study. A third of the scar will solely be treated with the 595nm PDL.

595/1064nm Multiplex Laser

595nm PDL DEVICE

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

595nm PDL

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fitzpatrick skin types 1-3
• Suture line should be at least 3 cm long

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Keyvan Nouri MD
• Organization: University of Miami

KNouri@med.miami.edu

305-243-3380

Study Officials

• Keyvan Nouri, MD

  University of Miami Sylvester Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Each participant scar was randomized to the 3 treatment arms.

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: June 15, 2015
• Study Start: January 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2017
• Last Updated: August 21, 2018
• Results First Posted: August 21, 2018

Record last verified: 2018-07

Locations

US (1)