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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each participant scar was randomized to the 3 treatment arms.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

595nm PDL

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

595/1064nm Multiplex Laser

Intervention Type DEVICE

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

595nm PDL

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No