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

Evaluating the Mechanism of Pain and Itch Reduction in Burn Scars Following Fractional Ablative CO2 Laser Treatment

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.

Study Overview

• Status: Recruiting
• Conditions: Burn Scar; Hypertrophic Scar
• Intervention / Treatment: Device: Luminis ultrapulse fractional ablative carbon dioxide laser

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.

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nisrine Kawa, MD; Phone Number: 6177242168; Email: nikawa@mgh.harvard.edu
• Study Contact Backup: Name: Domenic Annand, BS; Phone Number: 6176432242; Email: DANNAND@MGH.HARVARD.EDU

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Jonathan Friedstat, MD; Phone Number: 617-726-3712; Email: jfriedstat@mgh.harvard.edu
      • Contact: Domenic Annand, BS; Phone Number: 617-643-2242; Email: DANNAND@MGH.HARVARD.EDU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological change in nerve density	The investigators will stain the collected skin with markers specific to nerves to in order to count the number of nerves per biopsy area.	7 months
Histological change in nerve morphology	The investigators will stain the collected skin with markers specific to nerves to in order to compare the size and shape of cutaneous nerves before and after treatment. This will be based on subjective evaluation and not a predetermined scale.	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic Improvement Assessment	Patient Reported Outcome Measures will be collected via the Patient and Observer Scar Assessment Scale (POSAS). This is a validated questionnaire that includes 5 physician-completed parameters and 6 patient-reported measures. Each parameter is rated from 1-10 with a score of 1 representing "skin that appears close to normal" and 10 representing the "worst scare imaginable". Overall, the final score will range from 11( best outcome) to 110 (worst outcome). Physician parameters relate to the scar appearance such as color and thickness of the scar; while the patient-reported parameters also include symptomatic factors, such as degree of pain associated with the scar	7 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Jonathan Friedstat, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2020
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Itch
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Fibrosis; Burns; Cicatrix; Cicatrix, Hypertrophic
• Other Study ID Numbers: 2019P003424

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes