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

NCT ID: NCT01619917

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-01

Study Completion Date

2028-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Burn Scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Proximal

location of the scar proximal to heart

Group Type ACTIVE_COMPARATOR

Fractional Vascular Laser

Intervention Type DEVICE

laser energy will be applied to one of 2 sites (proximal or distal) depending on randomization result

Distal

location of scar distal to heart

Group Type EXPERIMENTAL

Fractional Vascular Laser

Intervention Type DEVICE

laser energy will be applied to one of 2 sites (proximal or distal) depending on randomization result

Interventions

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Fractional Vascular Laser

laser energy will be applied to one of 2 sites (proximal or distal) depending on randomization result

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Dr. Sarvesh Logsetty

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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S Logsetty, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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University of Manitoba

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Justin Gawaziuk, MSc

Role: CONTACT

[email protected]
2047893669

Facility Contacts

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Justin P Gawaziuk, MSc

Role: primary

[email protected]
2047873669

Other Identifiers

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B2011: 075

Identifier Type: -

Identifier Source: org_study_id