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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 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: April 16, 2014
Last verified: April 2014
  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

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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 2014
Estimated Primary Completion Date: December 2014 (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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619917

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

Locations
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         
Sponsors and Collaborators
University of Manitoba
Investigators
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: April 16, 2014
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 July 26, 2014