- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00482144
Study of the Effects of the Pulsed-dye Laser at 585nm and 595nm to Treat Post-operative Scars on Suture-removal Day
Comparison of the Effectiveness of the Pulsed Dye Laser 585nm Versus 595nm in the Treatment of New Surgical Scars
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- University of Miami Sylvester Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
|
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Vancouver Scar Scale Visual Analog Scale
Time Frame: 9 months
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale
Time Frame: 9 months
|
9 months
|
|
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
|
9 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1999-0694
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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