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Completed

NCT Number: NCT00482144

Study of the Effects of the Pulsed-dye Laser at 585nm and 595nm to Treat Post-operative Scars on Suture-removal Day

The purpose of this study is to compare the effects of the pulsed-dye laser (PDL) at two different wavelengths, 585nm and 595nm, in the treatment of post-surgical scars starting on suture-removal day.

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Key information

Conditions

Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Scars

Age range

18 year–65 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

Many treatment modalities have been used for the treatment of scars such as dermabrasion, cryotherapy, intralesional corticosteroids, surgical scar revision, and lasers, among others. Previous studies have shown that treatment of scars with the pulsed dye laser (PDL) alone or in combination with other modalities (e.g. corticosteroids, 5-Fluoruracil, silicone sheets) improves the vascularity, pliability, color, and height of hypertrophic scars and keloids. Currently, the PDL has become the laser of choice for the treatment of scars.

To our knowledge, there are no reports in the literature comparing the effects of different wavelengths of the PDL for the treatment of scars. The objective of this study was to compare the effects of the PDL at 585nm vs 595nm in the treatment of postsurgical linear scars starting the day of suture removal.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18-65
  • Postoperative linear scars greater than 6 cm
  • Skin photo-types I-IV

Exclusion criteria

  • Patient should not be taking any systemic, topical, or intralesional treatment of the scars

Treatment and study plan

PDL 450 microseconds

Procedure

The scar will be randomly divided into three equal fields. One third of the scar will receive PDL 585 nm using a 7 mm spot size at 4.0 J (Joules) for 450 microseconds. First treatment will be immediately after suture removal, and then monthly for 3 months.

PDL 1.5 milliseconds

Procedure

The scar will be randomly divided into three equal fields. One third of the scar will receive PDL 585 nm using a 7 mm spot size at 4.0 J (Joules) for 1.5 milliseconds. First treatment will be immediately after suture removal, and then monthly for 3 months.

Primary outcomes

  1. Vancouver Scar Scale Visual Analog Scale

    Time frame: 9 months

Secondary outcomes

  1. Visual Analog Scale

    Time frame: 9 months

  2. Blinded Evaluator assessments

    Time frame: 9 months

    The scar section will be compared in terms of: Pigmentation 0 normal color, close to normal skin 1 hypopigmentation 2 hyperpigmentation Vascularity 0 normal color, close to normal skin 1 pink, slight increase in blood supply 2 red, significant increase in blood supply 3 purple, excessive increase in blood supply Pliability 0 normal, normal pliability 1 supple, flexible with minimal resistance 2 yielding, giving way to pressure 3 firm, solid, inflexible unit 4 banding, rope-like tissue that blanches with extension of scar 5 contracture, permanent shortening Height 0 normal, flat 1 <2 mm 2 <5 mm 3 >5 mm

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Comparison of the Effectiveness of the Pulsed Dye Laser 585nm Versus 595nm in the Treatment of New Surgical Scars

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Jun 4, 2007
Registry last updated
Jun 28, 2016

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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