Laser Therapy for Treating Hypertrophic Burn Scars in Children (LaserTherapy)
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|ClinicalTrials.gov Identifier: NCT01653691|
Recruitment Status : Unknown
Verified July 2012 by Mattias Donelan, Massachusetts General Hospital.
Recruitment status was: Not yet recruiting
First Posted : July 31, 2012
Last Update Posted : July 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Burn Scars||Procedure: Pulse-Dye Laser Procedure: Sham||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Tunable-Dye Laser Therapy to Ameliorate Hypertrophic Scarring in Burned Children|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||January 2015|
Active Comparator: 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.
Procedure: 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.
Other Name: Candela V-Beam tunable dye laser.
Sham Comparator: 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.
No treatment to one side of subject's scar.
Other Name: No treatment
- Matching Assessment of Scars and Photographs [ Time Frame: 12 months after the first laser procedure is completed ]This scar assessment tool uses a set of reference photographs, a numeric scale, and location technique to measure change over time of a burn scar. This tool will assist us in determining the comparative merits of laser treatments. It is portable and inexpensive.
- Burn Outcomes Questionnaire [ Time Frame: Baseline completion after enrollment and again at 1st,2nd, 3rd, 4th,5th and 6th outpatient visits. ]The ABA/SHC Burn Outcomes Questionnaires are burn and age specific. Questions include those about itch, appearance and function; all elements of daily life that may be compromised by hypertrophic scars.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653691
|Contact: Martha Lydon, RN,BSfirstname.lastname@example.org|
|Contact: Michelle I Hinson, RNemail@example.com|
|United States, Ohio|
|Shriners Hospitals for Children||Not yet recruiting|
|Cincinnati, Ohio, United States, 45229-3095|
|Contact: Kevin Bailey, MD 513-872-6000 firstname.lastname@example.org|
|Contact: Richard Kagan, MD 513-872-6000 email@example.com|
|Principal Investigator: Kevin Bailey, MD|
|Principal Investigator:||Matthias Donelan, MD||Shriners Hospitals for Children-Boston MA USA|