Laser Therapy for Treating Hypertrophic Burn Scars in Children
NCT ID: NCT01653691
Last Updated: 2012-07-31
Study Results
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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UNKNOWN
NA
80 participants
INTERVENTIONAL
2012-05-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pulse Dye Laser, burn scars
A scar will be located on the study subject's torso or thigh and divided in half. Some subjects will receive laser to both sides of their scar, while others will not receive any intervention to one side and laser to the other side. Each side will be evaluated during outpatient visits. 12 months after treatment is completed, 2 burn experts will rate each side of the scar without knowing its treatment.
Pulse-Dye Laser
Laser therapy will be applied to either one half or both halves of the subject's burn scar. Laser will be re-applied every 4-6 weeks for a total of 3 administrations.
No treatment to half of scar
A scar on the child's torso or thigh will be divided in half. One side will receive laser treatment and the other half will receive laser or sham treatment.
Sham
No treatment to one side of subject's scar.
Interventions
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Pulse-Dye Laser
Laser therapy will be applied to either one half or both halves of the subject's burn scar. Laser will be re-applied every 4-6 weeks for a total of 3 administrations.
Sham
No treatment to one side of subject's scar.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* subject is clinically stable within 3 months of the burn injury.
* burn size of at least 15cm2 and able to be divided into equivalent halves (divided along line of tension). Equivalent orientation distance from mobil joint with regard to history,physical findings, proximity to tension producing forces and orientation.
* subjects in acute phase of burn injury generally less than one year from the time of the burn injury at 2-3 months post burn when deemed appropriate for pressure therapy, and have been evaluated as an appropriate candidate by a surgeon involved in this study for inclusion.
* subjects can be included up to one year post burn if referred from another treatment facility.
* no skin conditions that could potentially have an adverse effect on wound healing
* all race/ethnic groups
* children/guardians or significant others ability to speak English or Spanish and respond to study questionnaires.
* children/guardians or significant others inability to speak English or Spanish and respond to questionnaires.
* SUBJECTS WITH DOCUMENTED HYPERSENSITIVITY/ALLERGY TO AQUAPHOR,LIDOCAINE OR ANY OF THEIR COMPONENTS.
Exclusion Criteria
* subjects with no second degree burn to thigh and or trunk
* subjects with chemical burns
* subjects at low risk for hypertrophic scaring (wounds that demonstrate fading erythema at 9-12 weeks and wounds that are healed at less than 3 weeks are at low risk for hypertrophic scaring). Vancouver scar scale pigmentation rating of 0 or 1, vascularity rating of 0 or 1.
* TBSA greater than 50% as massive burns will confound results.
* potential life threatening injuries which would confound the effects of laser treatment and complicate sequential administration of therapy (e.g. shock,sepsis,inhalation therapies, brain injury).
9 Years
21 Years
ALL
No
Sponsors
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Shriners Hospitals for Children
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Mattias Donelan
Principal Investigator
Principal Investigators
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Matthias Donelan, MD
Role: PRINCIPAL_INVESTIGATOR
Shriners Hospitals for Children-Boston MA USA
Locations
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Shriners Hospitals for Children
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Kevin Bailey, MD
Role: primary
Richard Kagan, MD
Role: backup
Other Identifiers
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2010-P-002148
Identifier Type: -
Identifier Source: org_study_id