The Role of Pulsed Dye Laser Therapy in the Management of Burn Scars
Primary Purpose
Burn Scar
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
pulsed dye laser
Sponsored by
About this trial
This is an interventional treatment trial for Burn Scar focused on measuring burn, scar, laser
Eligibility 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
Sites / Locations
- University of Manitoba
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Proximal
Distal
Arm Description
part of scar proximal to heart
part of scar distal to heart
Outcomes
Primary Outcome Measures
Scar Characteristics
Examine characteristics of scar
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01488240
Brief Title
The Role of Pulsed Dye Laser Therapy in the Management of Burn Scars
Official Title
The Role of Pulsed Dye Laser Therapy in the Management of Burn Scars
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Scar
Keywords
burn, scar, laser
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proximal
Arm Type
Active Comparator
Arm Description
part of scar proximal to heart
Arm Title
Distal
Arm Type
Active Comparator
Arm Description
part of scar distal to heart
Intervention Type
Procedure
Intervention Name(s)
pulsed dye laser
Intervention Description
laser energy
Primary Outcome Measure Information:
Title
Scar Characteristics
Description
Examine characteristics of scar
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S Logsetty, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The Role of Pulsed Dye Laser Therapy in the Management of Burn Scars
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