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The Role of Pulsed Dye Laser Therapy in the Management of Burn Scars

This study is currently recruiting participants.
Verified November 2012 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01488240
First received: December 5, 2011
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to determine the effects (good or bad) of pulsed dye laser treatment in burn scar height, texture, redness and pliability in acute burn injury.


Condition Intervention Phase
Burn Scar
 Procedure: pulsed dye laser
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Pulsed Dye Laser Therapy in the Management of Burn Scars

Resource links provided by NLM:

MedlinePlus related topics: Burns Scars
U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Scar Characteristics [ Time Frame: six months ] [ Designated as safety issue: No ]
    Examine characteristics of scar


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
part of scar proximal to heart
 Procedure: pulsed dye laser
laser energy
Active Comparator: Distal
part of scar distal to heart
 Procedure: pulsed dye laser
laser energy

Detailed Description:

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 research group is proposing the commencement of two randomized controlled trial pilot studies assessing the effects of pulsed dye laser (PDL) on burn scars. The objectives of this project will be to determine the effectiveness of pulsed dye laser therapy on burn scar vascularity, pliability, height and texture. It has been hypothesized that the PDL works on acute injury to decrease scar formation, and the fractional laser works on scar that is quiescent to promote remodelling. Therefore the investigators are proposing to study both acute injury and late burn scars. This project will compare the effects of each laser type, and will either help support or refute the assertion that laser therapy can be used to improve burn scars.

Objectives:

To determine the benefit of pulsed dye laser treatment in improving burn scar height, texture, vascularity and pliability in acute burn injury.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • burn scar
  • living in Winnipeg
  • scar age one to 6 months
  • Fitzpatrick I-III skin type

Exclusion Criteria:

  • open wound
  • active infection
  • previous scar treatment with steroid injection or interferon
  • established disposition towards keloid scarring
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488240

Contacts
Contact: Justin P Gawaziuk, MSc 2047873669 jgawaziuk@hsc.mb.ca

Locations
Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: Justin P Gawaziuk, MSc     2047873669     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: University of Manitoba
ClinicalTrials.gov Identifier: NCT01488240     History of Changes
Other Study ID Numbers: B2011: 074
Study First Received: December 5, 2011
Last Updated: November 21, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
burn
scar
laser

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

ClinicalTrials.gov processed this record on June 18, 2013