- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01488240
The Role of Pulsed Dye Laser Therapy in the Management of Burn Scars
Study Overview
Detailed Description
While the literature tends to support the use of laser therapy in the management of burn scars, there is a definite lack of appropriately powered, randomized controlled trials. Laser therapy can be quite expensive when compared to other treatment modalities for burn scars, and while promising, its true usefulness has yet to be conclusively demonstrated. For this reason, our research group is proposing the commencement of two randomized controlled trial pilot studies assessing the effects of pulsed dye laser (PDL) on burn scars. The objectives of this project will be to determine the effectiveness of pulsed dye laser therapy on burn scar vascularity, pliability, height and texture. It has been hypothesized that the PDL works on acute injury to decrease scar formation, and the fractional laser works on scar that is quiescent to promote remodelling. Therefore the investigators are proposing to study both acute injury and late burn scars. This project will compare the effects of each laser type, and will either help support or refute the assertion that laser therapy can be used to improve burn scars.
Objectives:
To determine the benefit of pulsed dye laser treatment in improving burn scar height, texture, vascularity and pliability in acute burn injury.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Justin P Gawaziuk, MSc
- Phone Number: 2047873669
- Email: jgawaziuk@hsc.mb.ca
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3A 1R9
- Recruiting
- University of Manitoba
-
Contact:
- Justin P Gawaziuk, MSc
- Phone Number: 2047873669
- Email: jgawaziuk@hsc.mb.ca
-
Principal Investigator:
- Sarvesh Logsetty, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- burn scar
- living in Winnipeg
- scar age one to 6 months
- Fitzpatrick I-III skin type
Exclusion Criteria:
- open wound
- active infection
- previous scar treatment with steroid injection or interferon
- established disposition towards keloid scarring
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Proximal
part of scar proximal to heart
|
laser energy
|
|
Active Comparator: Distal
part of scar distal to heart
|
laser energy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Scar Characteristics
Time Frame: six months
|
Examine characteristics of scar
|
six months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: S Logsetty, MD, University of Manitoba
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2011: 074
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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