Laser Therapy for Treating Hypertrophic Burn Scars in Children (LaserTherapy)
Pulse-dye laser therapy has been used to treat the redness, tightness and discomfort of hypertrophic scars resulting from burn injuries. To date the effectiveness of laser therapy on children's burned scars has not been measured.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Tunable-Dye Laser Therapy to Ameliorate Hypertrophic Scarring in Burned Children|
- Matching Assessment of Scars and Photographs [ Time Frame: 12 months after the first laser procedure is completed ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
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
In this study we hope to answer an important question in pediatric burn care: what are the techniques whereby tunable-dye laser neo-vessel ablation is optimally employed to ameliorate hypertrophic scars resulting from burn injuries in children? Hypertrophic scarring is considered an adverse wound healing event that results in abnormal scar formation. This scarring process is associated with pruritis and discomfort and can interfere with function and aesthetics. Topical creams, massage, stretching and pressure are used as standard treatments of burn scar formation. With the child serving as their own control, we want to objectively measure the impact of PDL on burn scars in children. Variables of timing of application, duration and number of sessions will all be collected.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653691
|Contact: Martha Lydon, RN,BSemail@example.com|
|Contact: Michelle I Hinson, RNfirstname.lastname@example.org|
|United States, Ohio|
|Shriners Hospitals for Children||Not yet recruiting|
|Cincinnati, Ohio, United States, 45229-3095|
|Contact: Kevin Bailey, MD 513-872-6000 email@example.com|
|Contact: Richard Kagan, MD 513-872-6000 firstname.lastname@example.org|
|Principal Investigator: Kevin Bailey, MD|
|Principal Investigator:||Matthias Donelan, MD||Shriners Hospitals for Children-Boston MA USA|