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

Primary Purpose

Burn Scars

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pulse-Dye Laser

Sham

About this trial

This is an interventional treatment trial for Burn Scars focused on measuring Pediatric, Burns, Scars, Pulse Dye laser

Eligibility Criteria

9 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Shriners Hospitals for Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Pulse Dye Laser, burn scars

No treatment to half of scar

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Burn Outcomes Questionnaire

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.

Full Information

NCT ID

NCT01653691

First Posted

July 27, 2012

Last Updated

July 30, 2012

Sponsor

Massachusetts General Hospital

Collaborators

Shriners Hospitals for Children

1. Study Identification

Unique Protocol Identification Number

NCT01653691

Brief Title

Laser Therapy for Treating Hypertrophic Burn Scars in Children

Acronym

LaserTherapy

Official Title

Tunable-Dye Laser Therapy to Ameliorate Hypertrophic Scarring in Burned Children

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Unknown status

Study Start Date

May 2012 (undefined)

Primary Completion Date

March 2014 (Anticipated)

Study Completion Date

January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Shriners Hospitals for Children

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burn Scars

Keywords

Pediatric, Burns, Scars, Pulse Dye laser

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pulse Dye Laser, burn scars

Arm Type

Active Comparator

Arm Description

Arm Title

No treatment to half of scar

Arm Type

Sham Comparator

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Pulse-Dye Laser

Other Intervention Name(s)

Candela V-Beam tunable dye laser.

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Sham

Other Intervention Name(s)

No treatment

Intervention Description

No treatment to one side of subject's scar.

Primary Outcome Measure Information:

Title

Matching Assessment of Scars and Photographs

Description

Time Frame

12 months after the first laser procedure is completed

Secondary Outcome Measure Information:

Title

Burn Outcomes Questionnaire

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Martha Lydon, RN,BS

Phone

617-371-4808

mlydon@shrinenet.org

First Name & Middle Initial & Last Name or Official Title & Degree

Michelle I Hinson, RN

Phone

617-371-4809

mhinson@shrinenet.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthias Donelan, MD

Organizational Affiliation

Shriners Hospitals for Children-Boston MA USA

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shriners Hospitals for Children

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229-3095

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kevin Bailey, MD

Phone

513-872-6000

kbailey@shrinenet.org

First Name & Middle Initial & Last Name & Degree

Richard Kagan, MD

Phone

513-872-6000

rkagan@shrinenet.org

First Name & Middle Initial & Last Name & Degree

Kevin Bailey, MD

12. IPD Sharing Statement

Learn more about this trial

Laser Therapy for Treating Hypertrophic Burn Scars in Children

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