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

Not Applicable

Completed

• Conditions: Scars; Cicatrix
• Interventions: Procedure: PDL 1.5 milliseconds; Procedure: PDL 450 microseconds

• Registration Number: NCT00482144
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2007-06-01
• Study First Submitted QC: 2007-06-01
• Study First Posted: 2007-06-04
• Primary Completion: 2008-01
• Study Completion: 2008-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-26
• Last Update Posted: 2016-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment: PDL 1.5 milliseconds	PDL 1.5 milliseconds	The scar will be randomly divided into three equal fields. One third of the scar will receive PDL 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.
Treatment: PDL 450 microseconds	PDL 450 microseconds	The scar will be randomly divided into three equal fields. One third of the scar will receive PDL 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.

Primary Outcome Measures

Name	Time	Method
Vancouver Scar Scale Visual Analog Scale	9 months

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale	9 months
Blinded Evaluator assessments	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

Trial Locations

Locations (1)

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