Plasma Therapy for Scar Management

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Plasma 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.

Первичные конечные точки

• Change in Vancouver Scar Scale (VSS) Score [Срок оценки: Baseline to 1 month after treatment completion (Week 12)]

Вторичные конечные точки (5)

• Change in Pruritus Score [Срок оценки: Baseline to Week 12, Month 6]
• Change in Pain Score [Срок оценки: Baseline to Week 12, Month 6]
• Change in Scar Thickness [Срок оценки: Baseline to Week 12, Month 6]
• Patient Satisfaction [Срок оценки: Month 6]
• Recurrence Rate [Срок оценки: Month 6]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07548593 · SYSU-PLASMA-SCAR-2026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗