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Procedure
CO2 Laser for Hypertrophic Burn Scars
N/A
Recruiting
Led By Jonathan Friedstat, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be able to answer surveys on their own, and not rely on surrogates
Patients must be 18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 months (from first treatment to follow-up)
Awards & highlights
Study Summary
This trial will evaluate the effectiveness of laser treatment and punch biopsies for improving burn scars & patient's quality of life.
Who is the study for?
This trial is for adults over 18 with hypertrophic burn scars (HTBS) from burns, who are medically fit for laser treatment and not on medications that affect wound healing. They should be planning to undergo laser treatment but have areas untreated for the study. Pregnant individuals or those planning pregnancy during the study phase are excluded.Check my eligibility
What is being tested?
The trial tests a fractional ablative carbon dioxide laser against a control of no treatment and punch biopsies, which remove tissue without burning. It aims to see if these methods improve scarring in burn survivors by comparing treated scar areas through photographs, surveys, and microscopic tissue analysis.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site of treatment, changes in skin pigmentation, swelling, redness, and a risk of infection or delayed healing post-procedure. The severity can vary among patients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can complete surveys by myself without help.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 months (from first treatment to follow-up)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 months (from first treatment to follow-up)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Vancouver Scar Scale
Secondary outcome measures
Gene expression
elasticity of treatment areas of scar
histology of treatment areas of scar
+1 moreOther outcome measures
Patient Reported Outcome Measures Burn Specific
Patient Reported Outcome Measures Generic
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: LaserExperimental Treatment1 Intervention
Laser treatment to 3x3cm2 area. It will receive the Luminous ultra pulse fractional ablative carbon dioxide laser at 150mJ, 3% density and 250Hz.
Group II: 0.5mm punch biopsyExperimental Treatment1 Intervention
0.5mm punch biopsy area. This area will receive 0.5mm punch biopsies 75 per cm2 at a depth of 5mm.
Group III: No treatmentActive Control1 Intervention
3x3cm2 area designated as no treatment that will serve as a control
Find a Location
Who is running the clinical trial?
United States Department of DefenseFED
859 Previous Clinical Trials
225,511 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,924 Previous Clinical Trials
13,193,303 Total Patients Enrolled
Jonathan Friedstat, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
28 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My scar is not tight or thickened in a way that surgery would be better.I am unable to complete health surveys by myself due to cognitive reasons.I can complete surveys by myself without help.My burn injury was treated with skin grafts or healed on its own.My burn injury was treated with skin grafts or healed on its own.I am planning to get laser treatment for my painful scar, not just the one being studied.I am 18 years old or older.I don't have any health issues that prevent me from undergoing laser treatments or general anesthesia.I am planning to get laser treatment for my bothersome skin bumps, not just the study scar.I am healthy enough for laser or reconstructive surgery.My study scar is not near areas needing surgery.I am healthy enough for laser or reconstructive surgery.I can complete surveys by myself without help.I am not on steroids, immunosuppressants, chemotherapy, or medications that affect wound healing or immunity.I have had laser or reconstructive surgery on my scar or nearby tissue.
Research Study Groups:
This trial has the following groups:- Group 1: 0.5mm punch biopsy
- Group 2: Laser
- Group 3: No treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants still being admitted to this research project?
"According to information published on clinicaltrials.gov, this study is inviting participants and has been continually updated since its inception in March 20th 2019 until February 28th 2023."
Answered by AI
How many participants are enrolled in this medical trial at its full capacity?
"Correct. Records hosted on clinicaltrials.gov indicate that this medical trial, which was put up for public review on March 20th 2019, is actively recruiting individuals to the study; 120 participants are necessary from 1 site."
Answered by AI
Who else is applying?
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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