This study is a prospective, multicenter, real-world observational study. It aims to evaluate whether adding plasma device therapy to standard scar care is effective and safe for treating various types of scars, including hypertrophic scars, keloids, atrophic scars, postoperative scars, burn scars, and post-traumatic scars. A total of 400 patients receiving standard scar care plus plasma therapy will be enrolled from multiple hospitals across China. Their outcomes will be compared with 400 matched patients who received standard scar care alone. The main outcomes include change in Vancouver Scar Scale (VSS) score, pruritus relief, pain relief, scar thickness reduction, patient satisfaction, recurrence rate at 6 months, and any side effects. Patients will be followed for up to 6 months after treatment completion.
Study Type
OBSERVATIONAL
Enrollment
800
Cold atmospheric plasma device used for non-contact scar treatment. The device generates low-temperature plasma that modulates fibroblast proliferation, promotes collagen remodeling, reduces inflammation, and improves local microcirculation.
Change in Vancouver Scar Scale (VSS) Score
The Vancouver Scar Scale (VSS) assesses four parameters: vascularity (0-3), pigmentation (0-3), pliability (0-5), and height (0-3). Total score ranges from 0 to 15, with higher scores indicating more severe scarring. The primary outcome is the change from baseline in total VSS score at 1 month after completion of treatment (Week 12).
Time frame: Baseline to 1 month after treatment completion (Week 12)
Change in Pruritus Score
Numeric Rating Scale (NRS, 0-10) for itching severity, with 0 = no itch and 10 = worst possible itch.
Time frame: Baseline to Week 12, Month 6
Change in Pain Score
Visual Analog Scale (VAS, 0-10) for pain severity, with 0 = no pain and 10 = worst possible pain.
Time frame: Baseline to Week 12, Month 6
Change in Scar Thickness
Measured at the thickest point of the scar using high-frequency ultrasound or Vernier caliper.
Time frame: Baseline to Week 12, Month 6
Patient Satisfaction
ssessed using a 5-point scale (very satisfied, satisfied, neutral, dissatisfied, very dissatisfied) at 6 months after treatment completion.
Time frame: Month 6
Recurrence Rate
Proportion of participants experiencing scar re-thickening or symptom recurrence within 6 months after treatment completion.
Time frame: Month 6
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