Laser Therapy for Treating Hypertrophic Burn Scars in Children (LaserTherapy)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2012 by Massachusetts General Hospital
Sponsor:
Collaborator:
Shriners Hospitals for Children
Information provided by (Responsible Party):
Mattias Donelan, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01653691
First received: July 27, 2012
Last updated: July 30, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Burn Scars
Procedure: Pulse-Dye Laser
Procedure: Sham

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
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)
Arms Assigned Interventions
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.
Procedure: Sham
No treatment to one side of subject's scar.
Other Name: No treatment

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

Ages Eligible for Study:   9 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653691

Contacts
Contact: Martha Lydon, RN,BS 617-371-4808 mlydon@shrinenet.org
Contact: Michelle I Hinson, RN 617-371-4809 mhinson@shrinenet.org

Locations
United States, Ohio
Shriners Hospitals for Children Not yet recruiting
Cincinnati, Ohio, United States, 45229-3095
Contact: Kevin Bailey, MD    513-872-6000    kbailey@shrinenet.org   
Contact: Richard Kagan, MD    513-872-6000    rkagan@shrinenet.org   
Principal Investigator: Kevin Bailey, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Shriners Hospitals for Children
Investigators
Principal Investigator: Matthias Donelan, MD Shriners Hospitals for Children-Boston MA USA
  More Information

No publications provided

Responsible Party: Mattias Donelan, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01653691     History of Changes
Other Study ID Numbers: 2010-P-002148
Study First Received: July 27, 2012
Last Updated: July 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Pediatric
Burns
Scars
Pulse Dye laser

Additional relevant MeSH terms:
Burns
Hypertrophy
Cicatrix
Wounds and Injuries
Pathological Conditions, Anatomical
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014