Last updated: February 28, 2023
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Scar Tissue
Hyponatremia
Skin Wounds
Treatment
N/AClinical Study ID
NCT04364217
2019P003424
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient must have a hypertrophic burn scar treated by skin grafts or allowed to healsecondarily
- 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 thehypertrophic 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
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 thehypertrophic burn scar
- Current treatment with other procedures or drugs (experimental or other) in area ofinterest
- Medications that interfere with wound healing (oral steroids, immunosuppressivemedications, 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 noalternative to the said agent exists
- The study area should not be part of a contracture or other hypertrophic scar thatwould be better treated with surgical procedures.
- The study scar must not be adjacent to/in continuity with areas of HTBS that areplanning to be treated with surgical interventions.
- Any other condition or laboratory value that would, in the professional opinion of theinvestigator, potentially affect the subject's response or the integrity of the dataor would pose an unacceptable risk to the subject
- Patient suffers from epilepsy or seizure disorder.
Study Design
Total Participants: 28
Study Start date:
June 25, 2020
Estimated Completion Date:
July 31, 2025
Study Description
Connect with a study center
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting

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