A Prospective, Multicenter, Real-World Observational Study of a Plasma Device for the Treatment of Hypertrophic Scars, Keloids, Atrophic Scars, Postoperative Scars, and Burn Scars
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 800
- 主要终点
- Change in Vancouver Scar Scale (VSS) Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Plasma Device (Device)
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.
结局指标
主要结局
Change in Vancouver Scar Scale (VSS) Score
时间窗: 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).
次要结局
- Change in Pruritus Score(Baseline to Week 12, Month 6)
- Change in Pain Score(Baseline to Week 12, Month 6)
- Change in Scar Thickness(Baseline to Week 12, Month 6)
- Patient Satisfaction(Month 6)
- Recurrence Rate(Month 6)
研究者
Hu Zhicheng
Professer
First Affiliated Hospital, Sun Yat-Sen University