Burn, CO2 Laser in Scars, Hypertrophic Scars, Scar Improvement by Laser
Conditions
Keywords
burn scar, hypertrophic scar, CO2 Laser, laser assisted drug delivery
Brief summary
Burn scars can sometimes heal in a way that causes them to become thick, raised, and stiff. These scars may itch, feel uncomfortable, limit movement, and affect how the skin looks. Because of this, many burn survivors look for treatments that can help improve both the appearance and the symptoms of their scars. One treatment that has shown promise is fractional CO₂ laser therapy. This laser creates tiny openings in the scar tissue that help soften the scar and stimulate the skin to remodel itself. These openings can also help medications applied to the skin reach deeper into the scar where they may work better. A steroid medication called triamcinolone is commonly used to treat these scars. Another medication, called 5-fluorouracil (5-FU), has been shown in prior studies to work well when combined with steroids, but it is usually given by injection, which can be painful and sometimes causes side effects. In this study, we will look at whether delivering these medications through the laser openings can improve scars more effectively. Each participant's scar will be divided into two halves. One side will receive both medications, and the other side will receive the steroid alone. By comparing the two sides of the same scar, we hope to better understand whether adding 5-FU provides additional benefit.
Interventions
DEVICEFractional Ablative CO₂ Laser
Fractional ablative CO₂ laser treatment will be applied to assigned hypertrophic burn scar segments to create microthermal treatment zones and facilitate laser-assisted delivery of topical/intralesional study medication.
DRUGTriamcinolone Acetonide
Triamcinolone acetonide will be administered to assigned hypertrophic burn scar segments following fractional ablative CO₂ laser treatment as part of laser-assisted corticosteroid delivery.
Fluorouracil will be administered in combination with triamcinolone acetonide to assigned hypertrophic burn scar segments following fractional ablative CO₂ laser treatment to evaluate whether adjunctive 5-fluorouracil improves scar outcomes compared with triamcinolone acetonide alone.
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participants, treating clinicians, and outcome assessors will be masked to treatment allocation. Study medications will be prepared and labeled in a manner that does not reveal group assignment. Treatment segments will be identified using coded allocation records, and outcome assessments will be performed using standardized evaluations without disclosure of the assigned treatment condition.
Intervention model description
Participants will serve as their own controls in a split-scar, randomized design. Each eligible hypertrophic burn scar will be divided into treatment segments, with one segment assigned to fractional CO₂ laser-assisted triamcinolone acetonide delivery and the paired segment assigned to fractional CO₂ laser-assisted triamcinolone acetonide plus 5-fluorouracil delivery.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Patient with hypertrophic scarring secondary to burn injury * Ages 18-89
Exclusion criteria
* Pregnant patients or patients of childbearing age, sexually active, and unwilling to utilize contraception * Children * Individuals that are cognitively impaired and unable to provide consent * Currently breastfeeding * Has taken oral retinoids within 6 months of study initiation * Prior laser or intralesional TAC/5-FU treatments for their hypertrophic scars * Active infection * Active malignancy * Known hypersensitivity to CO2 laser, TAC, or 5-FU * Known dihydropyrimidine dehydrogenase (DPD) deficiency (complete or partial), due to risk of systemic 5-FU toxicity * Systemic corticosteroid or immunosuppressive medication use * Intolerance to anesthesia * Known connective tissue disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient and Observer Scar Assessment Scale Version 2.0 | Baseline to 3 months after final laser treatment. Will possibly do extended review at 12 months after final laser treatment. | The primary outcome will be the change in scar thickness and pliability as measured by the Patient and Observer Scar Assessment Scale Version 2.0 (POSAS 2.0). Treated scar segments receiving fractional ablative CO₂ laser-assisted drug delivery with triamcinolone acetonide plus 5-fluorouracil will be compared with contralateral or adjacent split-scar segments receiving fractional ablative CO₂ laser-assisted delivery with triamcinolone acetonide alone. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vancouver Scar Scale Score | Baseline to 3 months after final laser treatment. Possibly will do extended review 12 months after final laser treatment. | Secondary outcome will include change in Vancouver Scar Scale score, including vascularity, pigmentation, pliability, and height, comparing scar segments treated with fractional ablative CO₂ laser-assisted delivery of triamcinolone acetonide plus 5-fluorouracil versus triamcinolone acetonide alone. |
| Change in Patient-Reported Scar Symptoms | Baseline to 3 months after final laser treatment | Patient-reported scar symptoms, including pain and pruritus, will be assessed before and after treatment. Symptom scores will be compared between split-scar segments treated with fractional ablative CO₂ laser-assisted delivery of triamcinolone acetonide plus 5-fluorouracil versus triamcinolone acetonide alone. |
Contacts
CONTACTArman J Fijany, MD
PRINCIPAL_INVESTIGATORIan A Powelson, MD
University of California, Davis
Outcome results
None listed