An interventional study of Luminis ultrapulse fractional ablative carbon dioxide laser and 0.5mm punch biopsy in Burns and Hypertrophic Scar, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
719 studies on the registry are indexed under Burns; 145 are open to participants now.
This study's enrollment of 17 is below the median of 40 across 524 interventional studies indexed under Burns.
Browse Burns studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Study Scar Inclusion Criteria:
For Extremities, no surgical treatment can be performed on joint space above or below the target area
Exclusion Criteria:
Laser treatment to 3x3cm2 area. It will receive the Luminous ultra pulse fractional ablative carbon dioxide laser at 150mJ, 3% density and 250Hz.
Procedure: Luminis ultrapulse fractional ablative carbon dioxide laser
0.5mm punch biopsy area. This area will receive 0.5mm punch biopsies 75 per cm2 at a depth of 5mm.
Procedure: 0.5mm punch biopsy
3x3cm2 area designated as no treatment that will serve as a control
This laser will target water molecules and ablate columns of tissue that are approximately 3mm deep.
punch biopsies will be performed to remove approximately equivalent volumes of tissue compared to the laser
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.
Time frame: 14 months (from first treatment to follow-up)
photography of treatment areas in scar for evaluation
Evaluation of photographs of the treatment areas in the study scar
Time frame: 14 months (from first treatment to follow-up)
elasticity of treatment areas of scar
Measure elasticity using a cutometer
Time frame: 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
Time frame: 14 months (from first treatment to follow-up)
Gene expression
Inflammatory gene expression will be evaluated between laser treatment and control tissue
Time frame: 14 months (from first treatment to follow-up)
Patient Reported Outcome Measures Burn Specific
LIBRE (Life Impact Burn Recovery Evaluation)
Time frame: 14 months (from first treatment to follow-up)
Patient Reported Outcome Measures Generic
PROMIS 28 (Patient-Reported Outcomes Measurement Information System)
Time frame: 14 months (from first treatment to follow-up)
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Plan to share: No
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital