Status:
WITHDRAWN
Pain and Itch Reduction in Burn Scars Treated With Fractional CO2 Laser
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Hypertrophic Scar
Burn Scar
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04364217
Start Date
June 25 2020
End Date
July 1 2025
Last Update
December 31 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114