The Role of Pulsed Dye 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):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01488240
First received: December 5, 2011
Last updated: April 16, 2014
Last verified: April 2014

December 5, 2011
April 16, 2014
November 2012
December 2014   (final data collection date for primary outcome measure)
Scar Characteristics [ Time Frame: six months ] [ Designated as safety issue: No ]
Examine characteristics of scar
scar size [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
Examine characteristics of scar
Complete list of historical versions of study NCT01488240 on ClinicalTrials.gov Archive Site
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The Role of Pulsed Dye Laser Therapy in the Management of Burn Scars
The Role of Pulsed Dye Laser Therapy in the Management of Burn Scars

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Burn Scar
Procedure: pulsed dye laser
laser energy
  • Active Comparator: Proximal
    part of scar proximal to heart
    Intervention: Procedure: pulsed dye laser
  • Active Comparator: Distal
    part of scar distal to heart
    Intervention: Procedure: pulsed dye 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 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Justin P Gawaziuk, MSc 2047873669 jgawaziuk@hsc.mb.ca
Canada
 
NCT01488240
B2011: 074
No
University of Manitoba
University of Manitoba
Not Provided
Principal Investigator: S Logsetty, MD University of Manitoba
University of Manitoba
April 2014

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