Randomized Control Trial of CO2 Laser to Treat Hypertrophic Burn Scar (NCT03692273) | Clinical Trial Compass
CompletedNot Applicable
Randomized Control Trial of CO2 Laser to Treat Hypertrophic Burn Scar
United States17 participantsStarted 2019-03-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must be 18 years of age or older
* 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
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
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vancouver Scar Scale
Timeframe: 14 months (from first treatment to follow-up)