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

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT00482144
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 3
• Duration (Months): 58
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cicatrix; Scars	Procedure: PDL 450 microseconds; Procedure: PDL 1.5 milliseconds	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of the Effectiveness of the Pulsed Dye Laser 585nm Versus 595nm in the Treatment of New Surgical Scars
• Study Start Date: Jul 1, 2003
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment: 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.	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.
Active Comparator: Treatment: 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.	Procedure: 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.
No Intervention: Control The scar will be randomly divided into three equal fields. One third of the scar will not receive treatment

Outcome Measures

Primary Outcome Measures

1. Vancouver Scar Scale Visual Analog Scale [9 months]

Secondary Outcome Measures

1. Visual Analog Scale [9 months]

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami

Investigators

• Principal Investigator: Keyvan Nouri, MD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Keyvan Nouri, Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT00482144
• Other Study ID Numbers: 1999-0694
• First Posted: Jun 4, 2007
• Last Update Posted: Jun 28, 2016
• Last Verified: Jun 1, 2016

• Keywords provided by Keyvan Nouri, Professor, University of Miami: Pulsed-Dye Laser
• Additional relevant MeSH terms: Cicatrix

Study Results

No Results Posted as of Jun 28, 2016