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The Role of Fractional Vascular Laser Therapy in the Management of Burn Scars

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
Dr. Sarvesh Logsetty, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01619917
First received: June 12, 2012
Last updated: November 6, 2014
Last verified: November 2014

June 12, 2012
November 6, 2014
November 2012
December 2015   (final data collection date for primary outcome measure)
reduction in scar appearance [ Time Frame: every 3 weeks to 15 weeks ] [ Designated as safety issue: No ]
examine with modified Vancouver Scar Scale
Same as current
Complete list of historical versions of study NCT01619917 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Role of Fractional Vascular Laser Therapy in the Management of Burn Scars
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Burn Scar
Device: Fractional Vascular Laser
laser energy will be applied to one of 2 sites (proximal or distal) depending on randomization result
  • Active Comparator: Proximal
    location of the scar proximal to heart
    Intervention: Device: Fractional Vascular Laser
  • Experimental: Distal
    location of scar distal to heart
    Intervention: Device: Fractional Vascular Laser
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Justin Gawaziuk, MSc 2047893669 jgawaziuk@hsc.mb.ca
Canada
 
NCT01619917
B2011: 075
No
Dr. Sarvesh Logsetty, University of Manitoba
University of Manitoba
Not Provided
Principal Investigator: S Logsetty, MD University of Manitoba
University of Manitoba
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP