The Role of Fractional Vascular Laser Therapy in the Management of Burn Scars
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Burn Scar |
Device: Fractional Vascular Laser |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Role of Fractional Vascular Laser Therapy in the Management of Burn Scars |
- reduction in scar appearance [ Time Frame: every 3 weeks to 15 weeks ] [ Designated as safety issue: No ]examine with modified Vancouver Scar Scale
| Estimated Enrollment: | 12 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Proximal
location of the scar proximal to heart
|
Device: Fractional Vascular Laser
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
|
Device: Fractional Vascular Laser
laser energy will be applied to one of 2 sites (proximal or distal) depending on randomization result
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Justin Gawaziuk, MSc | 2047893669 | jgawaziuk@hsc.mb.ca |
| Canada, Manitoba | |
| University of Manitoba | Not yet recruiting |
| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Contact: Justin Gawaziuk, MSc 2047873669 jgawaziuk@hsc.mb.ca | |
| Principal Investigator: Sarvesh Logsetty, MD | |
| University of Manitoba | Recruiting |
| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Contact: Justin P Gawaziuk, MSc 2037873669 jgawaziuk@hsc.mb.ca | |
| Principal Investigator: Sarvesh Logsetty, MD | |
| Principal Investigator: | S Logsetty, MD | University of Manitoba |
More Information
No publications provided
| Responsible Party: | Dr. Sarvesh Logsetty, Principal Investigator, University of Manitoba |
| ClinicalTrials.gov Identifier: | NCT01619917 History of Changes |
| Other Study ID Numbers: | B2011: 075 |
| Study First Received: | June 12, 2012 |
| Last Updated: | November 20, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Manitoba:
|
burn scar laser fractional vascular |
Additional relevant MeSH terms:
|
Burns Cicatrix Wounds and Injuries Fibrosis Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013