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NCT03692273 · ClinicalTrials.gov registry record · NA
Randomized Control Trial of CO2 Laser to Treat Hypertrophic Burn Scar
A NA study of Burns and Hypertrophic Scar, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT03692273 is a NA study of Burns and Hypertrophic Scar that has completed, run by Massachusetts General Hospital. The registered enrollment target is 17 participants, below the 83-participant average among 36 other Burns trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03692273, a NA study of Burns and Hypertrophic Scar, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- PROCEDURE Luminis ultrapulse fractional ablative carbon dioxide laser
- PROCEDURE 0.5mm punch biopsy
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2019-03-20 |
| Est. Completion | 2025-10-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03692273
The ClinicalTrials.gov registry entry for NCT03692273 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 83-participant average among 36 other Burns trials with a reported enrollment target (80% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Burns appearing as the primary indexed condition, and to 2 interventions - of which Luminis ultrapulse fractional ablative carbon dioxide laser is the first listed.
NCT03692273 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03692273 about?
NCT03692273 is a clinical study titled "Randomized Control Trial of CO2 Laser to Treat Hypertrophic Burn Scar". 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 th...
What is the current status of trial NCT03692273?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2019-03-20. Estimated completion is 2025-10-06.
What conditions does trial NCT03692273 study?
This clinical trial studies the following conditions: Burns, Hypertrophic Scar.
What interventions are being tested in trial NCT03692273?
The interventions under investigation include: Luminis ultrapulse fractional ablative carbon dioxide laser (PROCEDURE), 0.5mm punch biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT03692273?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03692273 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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