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

Not Applicable

Completed

• Conditions: Scar
• Interventions: Device: 595/1064nm Multiplex Laser; Device: 595nm PDL

• Registration Number: NCT02472405
• Lead Sponsor: University of Miami

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-03-02
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-15
• Primary Completion: 2016-11
• Study Completion: 2017-11
• Results First Submitted: 2018-06-18
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-24
• Last Update Submitted: 2018-07-24
• Results First Posted: 2018-08-21
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
595/1064nm Multiplex Laser	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.
595nm PDL	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.

Primary Outcome Measures

Name	Time	Method
POSAS (The Patient and Observer Scar Assessment Scale) Measure	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.

Trial Locations

Locations (1)

University of Miami Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States