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

Primary Purpose

Burn Scar

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Fractional Vascular Laser
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn Scar focused on measuring burn, scar, laser, fractional, vascular

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Manitoba

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Proximal

Distal

Arm Description

location of the scar proximal to heart

location of scar distal to heart

Outcomes

Primary Outcome Measures

reduction in scar appearance
examine with modified Vancouver Scar Scale

Secondary Outcome Measures

Full Information

First Posted
June 12, 2012
Last Updated
November 1, 2022
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT01619917
Brief Title
The Role of Fractional Vascular Laser Therapy in the Management of Burn Scars
Official Title
The Role of Fractional Vascular Laser Therapy in the Management of Burn Scars
Study Type
Interventional

2. Study Status

Record Verification Date
November 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
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

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, fractional, vascular

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proximal
Arm Type
Active Comparator
Arm Description
location of the scar proximal to heart
Arm Title
Distal
Arm Type
Experimental
Arm Description
location of scar distal to heart
Intervention Type
Device
Intervention Name(s)
Fractional Vascular Laser
Intervention Description
laser energy will be applied to one of 2 sites (proximal or distal) depending on randomization result
Primary Outcome Measure Information:
Title
reduction in scar appearance
Description
examine with modified Vancouver Scar Scale
Time Frame
every 3 weeks to 15 weeks

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: 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
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

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

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