Randomized Control Trial of CO2 Laser to Treat Hypertrophic Burn Scar

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.

Conditions

• Hypertrophic Scar
• Burns

Interventions

PROCEDURE

Luminis ultrapulse fractional ablative carbon dioxide laser

This laser will target water molecules and ablate columns of tissue that are approximately 3mm deep.

PROCEDURE

0.5mm punch biopsy

punch biopsies will be performed to remove approximately equivalent volumes of tissue compared to the laser

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Jonathan Friedstat, MD · Massachusetts General Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-20

Primary Completion

2025-10-06

Completion

2025-10-06

FDA Device

Yes

Countries

• United States

Study Locations