Pain and Itch Reduction in Burn Scars Treated With Fractional CO2 Laser

Mass General Brigham

Status

Withdrawn

Conditions

Hypertrophic Scar

Burn Scar

Treatments

Device: Luminis ultrapulse fractional ablative carbon dioxide laser

Study type

Interventional

Funder types

Other

Identifiers

NCT04364217

2019P003424

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.