Carbon Dioxide Laser-Assisted Delivery of Triamcinolone With or Without 5-Fluorouracil for Hypertrophic Burn Scars

N/ANot Yet RecruitingNCT07660120

University of California, Davis65 enrolled

Overview

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 (TAC) 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Burn Hypertrophic Scars

Interventions

Fractional Ablative CO₂ LaserDEVICE

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.

Triamcinolone AcetonideDRUG

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 (5-FU)DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Patient and Observer Scar Assessment Scale Version 3.0

The primary outcome will be the change in scar thickness and pliability as measured by the Patient and Observer Scar Assessment Scale Version 3.0 (POSAS 3.0). 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. The POSAS 3.0 Scale grades on a 5 point scale where both the patient and observer select one of the following for each scar description category: Not, Minimally, Moderately, Severely, or Extremely.

Time frame: Baseline to 3 months after final laser treatment. Will possibly do extended review at 12 months after final laser treatment.

Secondary Outcomes

Change in Vancouver Scar Scale Score

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. The Vancouver Scar scale grades on a scale of 0-3 for vascularity (Normal, pink, red, and purple). A scale of 0-5 is used for pliability (normal, supply, yielding, firm, ropes/bands, and contracture). A scale of 0-2 for pigmentation (normal, hypopigmentation, hyperpigmentation). A scale of 0-3 for height (flat, less than 2 mm, 2 to 5 mm, greater than 5 mm).

Time frame: Baseline to 3 months after final laser treatment. Possibly will do extended review 12 months after final laser treatment.

Change in Patient-Reported Scar Symptoms

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. The patient reported scar symptoms will be graded on a scale of 1-5 (not noticeable, noticeable, somewhat bothersome, very bothersome, and extremely bothersome).

Time frame: Baseline to 3 months after final laser treatment