Laser Therapy for Treating Hypertrophic Burn Scars in Children

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01653691
• Date of registration: 27/07/2012
• Prospective Registration: No
• Primary sponsor: Massachusetts General Hospital
• Public title: Laser Therapy for Treating Hypertrophic Burn Scars in Children LaserTherapy
• Scientific title: Tunable-Dye Laser Therapy to Ameliorate Hypertrophic Scarring in Burned Children
• Date of first enrolment: May 2012
• Target sample size: 80
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01653691
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Martha Lydon, RN,BS

• Name: Matthias Donelan, MD
• Affiliation: Shriners Hospitals for Children-Boston MA USA

• Name: Kevin Bailey, MD

Key inclusion & exclusion 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.



Age minimum: 9 Years
Age maximum: 21 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Burn Scars

Intervention(s)

Procedure: Pulse-Dye Laser

Procedure: Sham

Primary Outcome(s)

Matching Assessment of Scars and Photographs [Time Frame: 12 months after the first laser procedure is completed]

Secondary Outcome(s)

Burn Outcomes Questionnaire [Time Frame: Baseline completion after enrollment and again at 1st,2nd, 3rd, 4th,5th and 6th outpatient visits.]

Secondary ID(s)

2010-P-002148

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Shriners Hospitals for Children