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

This study is currently recruiting participants.
Verified November 2016 by Dr. Sarvesh Logsetty, University of Manitoba
Sponsor:
ClinicalTrials.gov Identifier:
NCT01619917
First Posted: June 14, 2012
Last Update Posted: November 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Sarvesh Logsetty, University of Manitoba
  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
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Fractional Vascular Laser Therapy in the Management of Burn Scars

Resource links provided by NLM:


Further study details as provided by Dr. Sarvesh Logsetty, University of Manitoba:

Primary Outcome Measures:
  • reduction in scar appearance [ Time Frame: every 3 weeks to 15 weeks ]
    examine with modified Vancouver Scar Scale


Estimated Enrollment: 12
Study Start Date: November 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619917


Contacts
Contact: Justin Gawaziuk, MSc 2047893669 jgawaziuk@hsc.mb.ca

Locations
Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: Justin P Gawaziuk, MSc    2037873669    jgawaziuk@hsc.mb.ca   
Principal Investigator: Sarvesh Logsetty, MD         
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: S Logsetty, MD University of Manitoba
  More Information

Responsible Party: Dr. Sarvesh Logsetty, Principal Investigator, University of Manitoba
ClinicalTrials.gov Identifier: NCT01619917     History of Changes
Other Study ID Numbers: B2011: 075
First Submitted: June 12, 2012
First Posted: June 14, 2012
Last Update Posted: November 15, 2016
Last Verified: November 2016

Keywords provided by Dr. Sarvesh Logsetty, University of Manitoba:
burn
scar
laser
fractional
vascular

Additional relevant MeSH terms:
Burns
Cicatrix
Wounds and Injuries
Fibrosis
Pathologic Processes