Randomized Control Trial of CO2 Laser to Treat Hypertrophic Burn Scar
NCT ID: NCT03692273
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2019-03-20
2025-10-06
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Laser
Laser treatment to 3x3cm2 area. It will receive the Luminous ultra pulse fractional ablative carbon dioxide laser at 150mJ, 3% density and 250Hz.
Luminis ultrapulse fractional ablative carbon dioxide laser
This laser will target water molecules and ablate columns of tissue that are approximately 3mm deep.
0.5mm punch biopsy
0.5mm punch biopsy area. This area will receive 0.5mm punch biopsies 75 per cm2 at a depth of 5mm.
0.5mm punch biopsy
punch biopsies will be performed to remove approximately equivalent volumes of tissue compared to the laser
No treatment
3x3cm2 area designated as no treatment that will serve as a control
No interventions assigned to this group
Interventions
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Luminis ultrapulse fractional ablative carbon dioxide laser
This laser will target water molecules and ablate columns of tissue that are approximately 3mm deep.
0.5mm punch biopsy
punch biopsies will be performed to remove approximately equivalent volumes of tissue compared to the laser
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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.
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Massachusetts General Hospital
OTHER
Responsible Party
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Jonathan Friedstat
Instructor of Surgery, Harvard Medical School
Principal Investigators
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Jonathan Friedstat, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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MB170043
Identifier Type: -
Identifier Source: org_study_id