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

Primary Purpose

Cicatrix, Scars

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PDL 450 microseconds
PDL 1.5 milliseconds
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cicatrix focused on measuring Pulsed-Dye Laser

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Miami Sylvester Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Treatment: PDL 450 microseconds

Treatment: PDL 1.5 milliseconds

Control

Arm Description

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.

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.

The scar will be randomly divided into three equal fields. One third of the scar will not receive treatment

Outcomes

Primary Outcome Measures

Vancouver Scar Scale Visual Analog Scale

Secondary Outcome Measures

Visual Analog Scale
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

Full Information

First Posted
June 1, 2007
Last Updated
June 26, 2016
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT00482144
Brief Title
Study of the Effects of the Pulsed-dye Laser at 585nm and 595nm to Treat Post-operative Scars on Suture-removal Day
Official Title
Comparison of the Effectiveness of the Pulsed Dye Laser 585nm Versus 595nm in the Treatment of New Surgical Scars
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cicatrix, Scars
Keywords
Pulsed-Dye Laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment: PDL 450 microseconds
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment: PDL 1.5 milliseconds
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The scar will be randomly divided into three equal fields. One third of the scar will not receive treatment
Intervention Type
Procedure
Intervention Name(s)
PDL 450 microseconds
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
PDL 1.5 milliseconds
Intervention Description
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 Outcome Measure Information:
Title
Vancouver Scar Scale Visual Analog Scale
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Visual Analog Scale
Time Frame
9 months
Title
Blinded Evaluator assessments
Description
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
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keyvan Nouri, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12534515
Citation
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. doi: 10.1046/j.1524-4725.2003.29014.x.
Results Reference
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Study of the Effects of the Pulsed-dye Laser at 585nm and 595nm to Treat Post-operative Scars on Suture-removal Day

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