Laser Therapy for Treating Hypertrophic Burn Scars in Children

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Burn Scars

In brief

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.

Key facts

Study ID

NCT01653691

Run by

Massachusetts General Hospital

People needed

80

Starts

2012-05-01

Expected to finish

2015-01-01

Last updated by the study team

2012-07-31

Who can join

Age: 9 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Shriners Hospitals for Children — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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