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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser | Experimental | 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 | Experimental | 0.5mm punch biopsy area. This area will receive 0.5mm punch biopsies 75 per cm2 at a depth of 5mm. |
|
| No treatment | No Intervention | 3x3cm2 area designated as no treatment that will serve as a control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luminis ultrapulse fractional ablative carbon dioxide laser | Procedure | This laser will target water molecules and ablate columns of tissue that are approximately 3mm deep. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 months (from first treatment to follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| photography of treatment areas in scar for evaluation | Evaluation of photographs of the treatment areas in the study scar | 14 months (from first treatment to follow-up) |
| elasticity of treatment areas of scar |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcome Measures Burn Specific | LIBRE (Life Impact Burn Recovery Evaluation) | 14 months (from first treatment to follow-up) |
| Patient Reported Outcome Measures Generic | PROMIS 28 (Patient-Reported Outcomes Measurement Information System) |
Inclusion Criteria:
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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Friedstat, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 6, 2025 | Apr 7, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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Patients will receive all three interventions (laser, 0.5mm punch biopsy, and no treatment) within their study scar.
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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.
| 0.5mm punch biopsy | Procedure | punch biopsies will be performed to remove approximately equivalent volumes of tissue compared to the laser |
|
Measure elasticity using a cutometer
| 14 months (from first treatment to follow-up) |
| histology of treatment areas of scar | tissue samples will be evaluates for changes in cell architecture, collagen, and cells within the scar | 14 months (from first treatment to follow-up) |
| Gene expression | Inflammatory gene expression will be evaluated between laser treatment and control tissue | 14 months (from first treatment to follow-up) |
| 14 months (from first treatment to follow-up) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |