Clinical trial NCT01653691: Laser Therapy for Treating Hypertrophic Burn Scars in Children
Official title: Tunable-Dye Laser Therapy to Ameliorate Hypertrophic Scarring in Burned Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burn Scars
Keywords: Pediatric
Burns
Scars
Pulse Dye laser
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Shriners Hospitals for Children
First posted: 2012-07-31
Enrollment: 80
Sex: ALL
Minimum age (years): 9
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* subjects 9 years and older to 21 years of age or younger with a second degree burn with erythema and the potential for hypertrophic scarring to the thigh and or trunk.
* 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.

Exclusion Criteria:

* subjects less than 9 years old as this age group is more fragile.
* 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).
* subjects with other inclusion criteria not met and evaluation by surgeon negative for inclusion in study.
* 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.

Primary outcomes:
measure: Matching Assessment of Scars and Photographs
timeFrame: 12 months after the first laser procedure is completed
Secondary outcomes:
measure: Burn Outcomes Questionnaire
timeFrame: Baseline completion after enrollment and again at 1st,2nd, 3rd, 4th,5th and 6th outpatient visits.
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Shriners Hospitals for Children
state: Ohio
Study officials:
affiliation: Shriners Hospitals for Children-Boston MA USA
name: Matthias Donelan, MD
role: PRINCIPAL_INVESTIGATOR
References: