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

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ClinicalTrials.gov Identifier: NCT01488240
Recruitment Status : Recruiting
First Posted : December 8, 2011
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Burn Scar Procedure: pulsed dye laser

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Pulsed Dye Laser Therapy in the Management of Burn Scars
Study Start Date : November 2012
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Scar Characteristics [ Time Frame: six months ]
    Examine characteristics of scar


Eligibility Criteria

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:

  • 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

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): 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

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT01488240     History of Changes
Other Study ID Numbers: B2011: 074
First Posted: December 8, 2011    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: November 2016

Keywords provided by University of Manitoba:
burn
scar
laser

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