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

Cicatrix Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482144
• Other study ID #: 1999-0694
• Status: Completed
• Phase: N/A
• First received: June 1, 2007
• Last updated: June 26, 2016
• Start date: July 2003
• Est. completion date: May 2008

Study information

• Verified date: June 2016
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cicatrix
• Scars

Intervention

Procedure:
• PDL 450 microseconds
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
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.

Locations

Country	Name	City	State
United States	University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (1)

Nouri K, Jimenez GP, Harrison-Balestra C, Elgart GW. 585-nm pulsed dye laser in the treatment of surgical scars starting on the suture removal day. Dermatol Surg. 2003 Jan;29(1):65-73; discussion 73. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vancouver Scar Scale Visual Analog Scale		9 months	No
Secondary	Visual Analog Scale		9 months	No
Secondary	Blinded Evaluator assessments	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	9 months	No