Wound Healing
Conditions
Brief summary
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.
Interventions
DEVICEPlasma 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.
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of scar requiring therapeutic intervention, including but not limited to hypertrophic scar, keloid, atrophic scar, postoperative linear scar, burn scar, post-traumatic scar, or post-acne scar. * Scar duration ≥ 3 months, in stable or proliferative phase. * Age ≥ 12 years (for minors under 18 years, informed consent must be provided by a parent or legal guardian). * Stable vital signs and able to tolerate scar treatment. * Understand and willing to participate and able to provide signed informed consent.
Exclusion criteria
* Active infection, ulceration, or malignant tumor involving the scar area. Severe uncontrolled systemic disease or major organ dysfunction (heart, lung, brain, etc.). * Psychiatric disorder that prevents compliance with treatment. * Presence of diseases (malignant tumor, autoimmune disease) or use of medications (high-dose corticosteroids: ≥40 mg prednisone or equivalent per day for ≥2 weeks) that may affect scar healing or assessment. * HIV positivity, clinical diagnosis of AIDS, or absolute neutrophil count (ANC) \< 1000 cells/mm³ during screening. * Pregnancy or breastfeeding. * Previous treatment of the scar area (e.g., laser, injection, surgery) without a washout period of ≥3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vancouver Scar Scale (VSS) Score | Baseline to 1 month after treatment completion (Week 12) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pruritus Score | Baseline to Week 12, Month 6 | Numeric Rating Scale (NRS, 0-10) for itching severity, with 0 = no itch and 10 = worst possible itch. |
| Change in Pain Score | Baseline to Week 12, Month 6 | Visual Analog Scale (VAS, 0-10) for pain severity, with 0 = no pain and 10 = worst possible pain. |
| Change in Scar Thickness | Baseline to Week 12, Month 6 | Measured at the thickest point of the scar using high-frequency ultrasound or Vernier caliper. |
| Patient Satisfaction | Month 6 | ssessed using a 5-point scale (very satisfied, satisfied, neutral, dissatisfied, very dissatisfied) at 6 months after treatment completion. |
| Recurrence Rate | Month 6 | Proportion of participants experiencing scar re-thickening or symptom recurrence within 6 months after treatment completion. |
Outcome results
None listed