- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01619917
The Role of Fractional Vascular Laser Therapy in the Management of Burn Scars
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 assessing the effects of fractional vascular lasers on burn scars. It has been hypothesized that the fractional vascular lasers work on mature scars to decrease scar formation, and the fractional laser works on scar that is quiescent to promote remodelling. The retexturing/ resurfacing of the laser theoretically can decrease the visibility of the mesh pattern created by meshed split thickness skin graft).
Objective:
To determine the benefit of fractional vascular laser treatment in improving burn scar height, texture, vascularity and pliability in late burn scars.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Justin Gawaziuk, MSc
- Phone Number: 2047893669
- 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:
- living in Winnipeg
- burn scar 6-12 months old
- Fitzpatrick skin type I-III
- thermal burn scar on trunk or extremities
Exclusion Criteria:
- open wound
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Proximal
location of the scar proximal to heart
|
laser energy will be applied to one of 2 sites (proximal or distal) depending on randomization result
|
|
Experimental: Distal
location of scar distal to heart
|
laser energy will be applied to one of 2 sites (proximal or distal) depending on randomization result
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
reduction in scar appearance
Time Frame: every 3 weeks to 15 weeks
|
examine with modified Vancouver Scar Scale
|
every 3 weeks to 15 weeks
|
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2011: 075
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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