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

Last updated: February 28, 2023
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Scar Tissue

Hyponatremia

Skin Wounds

Treatment

N/A

Clinical Study ID

NCT04364217
2019P003424
  • Ages 18-80
  • All Genders

Study 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 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.

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

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.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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