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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plasma Device Group | Patients receiving standard scar care (silicone gel, pressure therapy, scar cream, etc.) plus plasma device therapy. The plasma device is applied non-contact to the scar area at a distance of 5-10 mm, with power set to low/medium mode according to scar type. Treatment duration: 5-10 seconds per cm², total not exceeding 15 minutes per session. Frequency: once every 2 weeks, total 4-6 sessions as one course. After each session, repair dressing or antibiotic ointment is applied. |
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| Conventional Treatment Group | Patients receiving standard scar care alone, including silicone gel, pressure therapy, scar cream, etc., without plasma device therapy. Participants may be enrolled concurrently (not receiving plasma device) or identified retrospectively from medical records. Propensity score matching will be used to control for confounding factors. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma Device | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 1 month after treatment completion (Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pruritus Score | Numeric Rating Scale (NRS, 0-10) for itching severity, with 0 = no itch and 10 = worst possible itch. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be recruited from patients presenting with various types of scars (hypertrophic scars, keloids, atrophic scars, postoperative scars, burn scars, post-traumatic scars, post-acne scars) at the burn units, plastic surgery departments, or dermatology departments of 10 participating tertiary hospitals across China.
Eligible participants are those who require scar management and meet the inclusion criteria. Patients in the plasma device group will be enrolled prospectively from those receiving standard scar care plus plasma device therapy as part of their routine clinical care. Control group participants will be derived from either: (1) concurrent patients receiving standard scar care alone at the same centers, or (2) retrospectively identified patients from medical records who received standard scar care without plasma therapy. Propensity score matching will be applied to balance baseline characteristics between the two groups.
No special restrictions on gender,
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| 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. | 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. | Month 6 |
| Recurrence Rate | Proportion of participants experiencing scar re-thickening or symptom recurrence within 6 months after treatment completion. | Month 6 |