Purpose

Hypertrophic Burn Scars (HTBS) are often treated with Fractional CO2 laser therapy to improve cosmetic appearance. It has been noted that this leads to a reduction in the pain and itch associated with this type of scars. While this phenomenon is commonly described in the literature, the mechanism of pain and itch reduction in unclear. The investigators aim to better understand this process by histological evaluation of HTBS at different stages of laser treatment.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patient must have a hypertrophic burn scar treated by skin grafts or allowed to heal secondarily - Burn must have occurred within the last 2 years from time of recruitment - Patient must have symptoms of pain and/or itch and/or hypersensitivity in the hypertrophic burn scar area - Patient must already be planning to undergo laser treatment for their burn scar - Patient must be willing to undergo biopsy procedures - Patient must be willing and able to participate in the study with a year of follow-up - Not be pregnant or planning to become pregnant during the treatment phase of the study

Exclusion Criteria

  • Medical Conditions that preclude laser treatment - Active tanning, including the use of tanning booths, during the course of the study - Inability to complete surveys - Previous laser (PDL, CO2), surgical reconstructive treatment procedures done on the hypertrophic burn scar - Current treatment with other procedures or drugs (experimental or other) in area of interest - Medications that interfere with wound healing (oral steroids, immunosuppressive medications, chemotherapy or other) - Medication for itch (steroids, antihistamines, or other) - Medication for pain (opioids, topical pain treatment, gabapentin, ondasetron, paroxetine or other) - Adverse reactions to topical or local anesthetic agents needed for this study, if no alternative to the said agent exists - The study area should not be part of a contracture or other hypertrophic scar that would be better treated with surgical procedures. - The study scar must not be adjacent to/in continuity with areas of HTBS that are planning to be treated with surgical interventions. - Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject - Patient suffers from epilepsy or seizure disorder.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Treatment
Laser treatment to 3x3cm2 area. It will receive the Luminous ultra pulse fractional ablative carbon dioxide laser at 150mJ, 3% density and 250Hz
  • Device: Luminis ultrapulse fractional ablative carbon dioxide laser
    This laser will target water molecules and ablate columns of tissue that are approximately 3mm deep.
    Other names:
    • Fractional CO2 laser treatment

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Jonathan Friedstat, MD
617-726-3712
jfriedstat@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Nisrine Kawa, MD
6177242168
nikawa@mgh.harvard.edu

Detailed Description

During our study, patients with painful and/or itchy burn scars will undergo standard treatment with fractional CO2 laser. In addition to the standard of care treatment, participants will undergo skin biopsies and be asked to complete Patient Reported Outcome Measure questionnaires related to their HTBS. Burn scars will also undergo standard and 3 dimensional photography at the different stages of treatment. Biopsy samples will undergo various staining techniques to establish the changes in tissue that occur with the laser treatment. This information will also be correlated with the symptomatic changes.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.