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Completed

NCT Number: NCT02472405

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

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.

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Key information

Conditions

Scar Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

595nm PDL

Device

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

Primary outcomes

  1. POSAS (The Patient and Observer Scar Assessment Scale) Measure

    Time frame: 2 months

    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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 15, 2015
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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