Ignite Creation Date:
2024-05-06 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03692273
Status:
RECRUITING
Last Update Posted:
2023-03-02
First Post:
2018-09-29
Brief Title:
Randomized Control Trial of CO2 Laser to Treat Hypertrophic Burn Scar
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Within-Scar Randomized Control Trial Comparing Fractional Ablative Carbon Dioxide Laser to Non-Energy-Based Mechanical Tissue Extraction and No Treatment
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 05mm punch biopsies to controls to fill this knowledge gap
The hypothesis is the laser is beneficial at improving patients 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 patients quality of life patients will be asked a limited set of questions to learn more how these procedures improve their lives
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 05mm punch biopsies to controls to fill this knowledge gap
The hypothesis is the laser is beneficial at improving patients 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 patients quality of life patients will be asked a limited set of questions to learn more how these procedures improve their lives
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None