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

Primary Purpose

Hypertrophic Scar, Burn Scar

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Luminis ultrapulse fractional ablative carbon dioxide laser
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertrophic Scar focused on measuring Pain, Itch

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment

Arm Description

Laser treatment to 3x3cm2 area. It will receive the Luminous ultra pulse fractional ablative carbon dioxide laser at 150mJ, 3% density and 250Hz

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
March 6, 2020
Last Updated
February 28, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04364217
Brief Title
Pain and Itch Reduction in Burn Scars Treated With Fractional CO2 Laser
Official Title
Evaluating the Mechanism of Pain and Itch Reduction in Burn Scars Following Fractional Ablative CO2 Laser Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2020 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

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

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Scar, Burn Scar
Keywords
Pain, Itch

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Other
Arm Description
Laser treatment to 3x3cm2 area. It will receive the Luminous ultra pulse fractional ablative carbon dioxide laser at 150mJ, 3% density and 250Hz
Intervention Type
Device
Intervention Name(s)
Luminis ultrapulse fractional ablative carbon dioxide laser
Other Intervention Name(s)
Fractional CO2 laser treatment
Intervention Description
This laser will target water molecules and ablate columns of tissue that are approximately 3mm deep.
Primary Outcome Measure Information:
Title
Histological change in nerve density
Description
The investigators will stain the collected skin with markers specific to nerves to in order to count the number of nerves per biopsy area.
Time Frame
7 months
Title
Histological change in nerve morphology
Description
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.
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Symptomatic Improvement Assessment
Description
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
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nisrine Kawa, MD
Phone
6177242168
Email
nikawa@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Domenic Annand, BS
Phone
6176432242
Email
DANNAND@MGH.HARVARD.EDU
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Friedstat, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Friedstat, MD
Phone
617-726-3712
Email
jfriedstat@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Domenic Annand, BS
Phone
617-643-2242
Email
DANNAND@MGH.HARVARD.EDU

12. IPD Sharing Statement

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

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