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Randomized Control Trial of CO2 Laser to Treat Hypertrophic Burn Scar

Primary Purpose

Burns, Hypertrophic Scar

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Luminis ultrapulse fractional ablative carbon dioxide laser
0.5mm punch biopsy
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must be 18 years of age or older
  • Must be medically fit to undergo laser/reconstructive procedure
  • Must have symptomatic HTBS for which they are already planning to undergo laser treatment. The symptomatic HTBSs may include the study scar area, but there must be other areas that the patient is getting treated with laser besides the study scar.
  • The HTBS must have occurred from a burn injured area either treated by skin grafts or allowed to heal secondarily.
  • Be willing and able to participate in the study with a year of follow-up
  • Must be able to answer surveys on their own, and not rely on surrogates
  • Not be pregnant or planning to become pregnant during the treatment phase of the study

Study Scar Inclusion Criteria:

  • The study scar must be at least 3mm thick

  • For Extremities, no surgical treatment can be performed on joint space above or below the target area

    • If the study scar is over a joint, then no surgical treatments can occur to the body part above or below it
  • When the study scar is on the trunk or neck, it must not be on continuity or adjacent to any area of planned surgical treatment.
  • Study Scar Size: The study scar can either be within an area of homogenous HTBS or be an area of HTBS surrounded by normal tissue if it meets the following size criteria:
  • Within HTBS For treatment areas within burn scars, it must be 65cm2 or larger to permit 3 treatment areas that are 3 x 3cm with a 1cm wide segment of untreated scar between it.
  • Surrounded by normal tissue For treatment areas surrounded by normal skin, the treatment area must be 33cm2 or greater, contain similar 3x3cm treatment areas, and have intervening segments of 1cm of scar between treatment areas. A border around the scar, is not required here because it is surrounded by normal skin.

Exclusion Criteria:

  • Previous laser or reconstructive procedures for the treatment of their HTBS in the study scar or adjacent tissue.
  • Steroids, immunosuppressive medications, chemotherapy or other medications that can delay their wound healing/immune function.
  • Medical Conditions that preclude laser treatment or general anesthesia if needed
  • Cognitively unable to complete PROMs on their own
  • 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.

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Laser

0.5mm punch biopsy

No 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.

0.5mm punch biopsy area. This area will receive 0.5mm punch biopsies 75 per cm2 at a depth of 5mm.

3x3cm2 area designated as no treatment that will serve as a control

Outcomes

Primary Outcome Measures

Vancouver Scar Scale
scar scale to evaluate severity of hypertrophic burn scars This is a 3 question scale, the first question graded from 0-3, the second and third questions graded from 0-5. The final score is the sum of the scores of the three questions, giving a possible total score range of 0-13. The higher the score, the worse the outcome.

Secondary Outcome Measures

photography of treatment areas in scar for evaluation
Evaluation of photographs of the treatment areas in the study scar
elasticity of treatment areas of scar
Measure elasticity using a cutometer
histology of treatment areas of scar
tissue samples will be evaluates for changes in cell architecture, collagen, and cells within the scar
Gene expression
Inflammatory gene expression will be evaluated between laser treatment and control tissue

Full Information

First Posted
September 29, 2018
Last Updated
February 28, 2023
Sponsor
Massachusetts General Hospital
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT03692273
Brief Title
Randomized Control Trial of CO2 Laser to Treat Hypertrophic Burn Scar
Official Title
A Within-Scar, Randomized Control Trial Comparing Fractional Ablative Carbon Dioxide Laser to Non-Energy-Based, Mechanical Tissue Extraction and No Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
United States Department of Defense

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.
No

5. Study Description

Brief Summary
Laser treatment of hypertrophic burn scars has become increasingly popular for improving scarring in burn survivors. Despite its common use, there a gap in knowledge regrading randomized control trials that demonstrate whether the laser is beneficial. Such a trial is important because if it shows the laser does work, it would provide the evidence to make such treatments more accessible to all patients. Furthermore, there is no knowledge whether the burn injury used to remove tissue is beneficial or not. This study aims to evaluate the laser treatment, removal of similar tissue amounts with 0.5mm punch biopsies, to controls to fill this knowledge gap. The hypothesis is the laser is beneficial at improving patient's burn scars. Also the punch biopsies work better at improving scars by removing tissue without burning and injuring the surrounding tissue as the laser does. To evaluate these treatments (laser, punch biopsies, and no treatment), 3 small areas will be chosen in a study scar area that meets specific criteria to receive . Patients will still be able to receive laser and burn reconstruction procedures in all other areas not involving the study scar area that are clinically indicated. In the study, the scar will be evaluated with photographs, surveys, and tissue samples taken either while under anesthesia except for one set taken with numbing medicine. The tissue samples will be looked at under a microscope to see how the treatments change the scar tissue. The tissue will also have tests done to evaluate how the laser impacts genes from cells in the scar tissue. Lastly, to understand how reconstructive procedures (laser and surgical treatments) change a patient's quality of life, patients will be asked a limited set of questions to learn more how these procedures improve their lives.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Hypertrophic Scar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will receive all three interventions (laser, 0.5mm punch biopsy, and no treatment) within their study scar.
Masking
Outcomes Assessor
Masking Description
The provider and patient will know which area is randomized to the three treatments. The assessors of the primary and secondary outcomes will be blinded to which treatment was provided to each of the three areas within the study scar.
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laser
Arm Type
Experimental
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.
Arm Title
0.5mm punch biopsy
Arm Type
Experimental
Arm Description
0.5mm punch biopsy area. This area will receive 0.5mm punch biopsies 75 per cm2 at a depth of 5mm.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
3x3cm2 area designated as no treatment that will serve as a control
Intervention Type
Procedure
Intervention Name(s)
Luminis ultrapulse fractional ablative carbon dioxide laser
Intervention Description
This laser will target water molecules and ablate columns of tissue that are approximately 3mm deep.
Intervention Type
Procedure
Intervention Name(s)
0.5mm punch biopsy
Intervention Description
punch biopsies will be performed to remove approximately equivalent volumes of tissue compared to the laser
Primary Outcome Measure Information:
Title
Vancouver Scar Scale
Description
scar scale to evaluate severity of hypertrophic burn scars This is a 3 question scale, the first question graded from 0-3, the second and third questions graded from 0-5. The final score is the sum of the scores of the three questions, giving a possible total score range of 0-13. The higher the score, the worse the outcome.
Time Frame
14 months (from first treatment to follow-up)
Secondary Outcome Measure Information:
Title
photography of treatment areas in scar for evaluation
Description
Evaluation of photographs of the treatment areas in the study scar
Time Frame
14 months (from first treatment to follow-up)
Title
elasticity of treatment areas of scar
Description
Measure elasticity using a cutometer
Time Frame
14 months (from first treatment to follow-up)
Title
histology of treatment areas of scar
Description
tissue samples will be evaluates for changes in cell architecture, collagen, and cells within the scar
Time Frame
14 months (from first treatment to follow-up)
Title
Gene expression
Description
Inflammatory gene expression will be evaluated between laser treatment and control tissue
Time Frame
14 months (from first treatment to follow-up)
Other Pre-specified Outcome Measures:
Title
Patient Reported Outcome Measures Burn Specific
Description
LIBRE (Life Impact Burn Recovery Evaluation)
Time Frame
14 months (from first treatment to follow-up)
Title
Patient Reported Outcome Measures Generic
Description
PROMIS 28 (Patient-Reported Outcomes Measurement Information System)
Time Frame
14 months (from first treatment to follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be 18 years of age or older Must be medically fit to undergo laser/reconstructive procedure Must have symptomatic HTBS for which they are already planning to undergo laser treatment. The symptomatic HTBSs may include the study scar area, but there must be other areas that the patient is getting treated with laser besides the study scar. The HTBS must have occurred from a burn injured area either treated by skin grafts or allowed to heal secondarily. Be willing and able to participate in the study with a year of follow-up Must be able to answer surveys on their own, and not rely on surrogates Not be pregnant or planning to become pregnant during the treatment phase of the study Study Scar Inclusion Criteria: The study scar must be at least 3mm thick For Extremities, no surgical treatment can be performed on joint space above or below the target area If the study scar is over a joint, then no surgical treatments can occur to the body part above or below it When the study scar is on the trunk or neck, it must not be on continuity or adjacent to any area of planned surgical treatment. Study Scar Size: The study scar can either be within an area of homogenous HTBS or be an area of HTBS surrounded by normal tissue if it meets the following size criteria: Within HTBS For treatment areas within burn scars, it must be 65cm2 or larger to permit 3 treatment areas that are 3 x 3cm with a 1cm wide segment of untreated scar between it. Surrounded by normal tissue For treatment areas surrounded by normal skin, the treatment area must be 33cm2 or greater, contain similar 3x3cm treatment areas, and have intervening segments of 1cm of scar between treatment areas. A border around the scar, is not required here because it is surrounded by normal skin. Exclusion Criteria: Previous laser or reconstructive procedures for the treatment of their HTBS in the study scar or adjacent tissue. Steroids, immunosuppressive medications, chemotherapy or other medications that can delay their wound healing/immune function. Medical Conditions that preclude laser treatment or general anesthesia if needed Cognitively unable to complete PROMs on their own 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Chang
Phone
617-726-3712
Email
kchang14@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jen Levin
Phone
617-726-3712
Email
jlevin7@partners.org
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
Phone
617-726-7312
Email
jfriedstat@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Randomized Control Trial of CO2 Laser to Treat Hypertrophic Burn Scar

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