Laser Therapy for Treating Hypertrophic Burn Scars in Children

Burn Scars Clinical Trial

— LaserTherapy  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01653691
• Other study ID #: 2010-P-002148
• Status: Not yet recruiting
• Phase: N/A
• First received: July 27, 2012
• Last updated: July 30, 2012
• Start date: May 2012
• Est. completion date: January 2015

Study information

• Verified date: July 2012
• Source: Massachusetts General Hospital
• Contact: Martha Lydon, RN,BS
• Phone: 617-371-4808
• Email: mlydon[@]shrinenet.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 21 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burn Scars

Intervention

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.
• Sham
No treatment to one side of subject's scar.

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Baseline completion after enrollment and again at 1st,2nd, 3rd, 4th,5th and 6th outpatient visits.	No