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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
Must not have
Medical Conditions that preclude laser treatment or general anesthesia if needed
Cognitively unable to complete PROMs on their own
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 months (from first treatment to follow-up)
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I can complete surveys by myself without help.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I don't have any health issues that prevent me from undergoing laser treatments or general anesthesia.
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I am unable to complete health surveys by myself due to cognitive reasons.
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My study scar is not near areas needing surgery.
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I have had laser or reconstructive surgery on my scar or nearby tissue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 months (from first treatment to follow-up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 months (from first treatment to follow-up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Vancouver Scar Scale
Secondary study objectives
Gene expression
elasticity of treatment areas of scar
histology of treatment areas of scar
+1 more
Other study objectives
Patient Reported Outcome Measures Burn Specific
Patient Reported Outcome Measures Generic

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
910 Previous Clinical Trials
333,611 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
3,015 Previous Clinical Trials
13,309,240 Total Patients Enrolled
Jonathan Friedstat, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
28 Total Patients Enrolled

Media Library

0.5mm punch biopsy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03692273 — N/A
Hypertrophic Scar Research Study Groups: 0.5mm punch biopsy, Laser, No treatment
Hypertrophic Scar Clinical Trial 2023: 0.5mm punch biopsy Highlights & Side Effects. Trial Name: NCT03692273 — N/A
0.5mm punch biopsy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03692273 — N/A
~0 spots leftby Dec 2024
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