Laser Therapy for Treating Hypertrophic Burn Scars in Children

NCT01653691 | Unknown

• 1 other identifier: 2010-P-002148
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Scars

Keywords

Pediatric; Burns; Scars; Pulse Dye laser

Outcome Measures

Primary Outcomes (1)

• Matching Assessment of Scars and Photographs

  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.

  12 months after the first laser procedure is completed

Secondary Outcomes (1)

• Burn Outcomes Questionnaire

  Baseline completion after enrollment and again at 1st,2nd, 3rd, 4th,5th and 6th outpatient visits.

Study Arms (2)

Pulse Dye Laser, burn scars

ACTIVE COMPARATOR

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

No treatment to half of scar

SHAM COMPARATOR

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.

Procedure: Sham

Interventions

Pulse-Dye Laser PROCEDURE

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.

Also known as: Candela V-Beam tunable dye laser.

Pulse Dye Laser, burn scars

Sham PROCEDURE

No treatment to one side of subject's scar.

Also known as: No treatment

No treatment to half of scar

Eligibility Criteria

• Age: 9 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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 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).
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Shriners Hospitals for Children: collaborator

Study Sites (1)

Shriners Hospitals for Children

Cincinnati, Ohio, 45229-3095, United States

Location

MeSH Terms

Conditions

Burns; Cicatrix

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Wounds and Injuries; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthias Donelan, MD

  Shriners Hospitals for Children-Boston MA USA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martha Lydon, RN,BS

CONTACT

617-371-4808; mlydon@shrinenet.org

Michelle I Hinson, RN

CONTACT

617-371-4809; mhinson@shrinenet.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: July 31, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: January 1, 2015
• Last Updated: July 31, 2012

Record last verified: 2012-07

Locations

US (1)