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

NCT ID: NCT01488240

Last Updated: 2024-12-05

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

2027-06-01

Brief Summary

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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

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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 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.

Conditions

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Burn Scar

Keywords

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burn scar laser

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Proximal

part of scar proximal to heart

Group Type ACTIVE_COMPARATOR

pulsed dye laser

Intervention Type PROCEDURE

laser energy

Distal

part of scar distal to heart

Group Type ACTIVE_COMPARATOR

pulsed dye laser

Intervention Type PROCEDURE

laser energy

Interventions

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pulsed dye laser

laser energy

Intervention Type PROCEDURE

Eligibility Criteria

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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
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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Responsibility Role SPONSOR

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 P Gawaziuk, MSc

Role: CONTACT

Phone: 2047873669

Email: [email protected]

Facility Contacts

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Justin P Gawaziuk, MSc

Role: primary

Other Identifiers

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B2011: 074

Identifier Type: -

Identifier Source: org_study_id