Plasma Therapy for Diverse Wounds

Официальное название

A Prospective, Multicenter, Real-World Observational Study of a Plasma Device for Adjunctive Therapy in Acute Wounds, Chronic Wounds, Post-Grafting Wounds, and Sutured Wounds

Обзор

This study is a prospective, multicenter, real-world observational study. It aims to evaluate whether adding plasma device therapy to standard wound care is effective and safe for treating different types of wounds, including acute wounds (such as burns and surgical incisions), chronic wounds (such as diabetic foot ulcers and pressure injuries), post-grafting wounds, and sutured wounds. A total of 500 patients receiving standard wound care plus plasma therapy will be enrolled from multiple hospitals across China. Their outcomes will be compared with 500 matched patients who received standard wound care alone. The main outcomes include wound healing rate at 4 weeks, time to complete wound closure, pain relief, scar formation, and any side effects. Patients will be followed for up to 6 months.

Вмешательства

• Устройство Plasma Device
  Cold atmospheric plasma device used for non-contact wound treatment. The device generates low-temperature plasma with broad-spectrum antibacterial properties, promoting cell proliferation, modulating inflammation, and improving local microcirculation.

Первичные конечные точки

• Complete Wound Healing Rate at 4 Weeks [Срок оценки: 4 weeks after enrollment]
• Proportion of Wounds Achieving ≥50% Area Reduction at 4 Weeks [Срок оценки: 4 weeks after enrollment]

Вторичные конечные точки (8)

• Time to Complete Wound Healing [Срок оценки: From enrollment to complete epithelialization, assessed up to 6 months]
• Change in Pain Score (VAS) [Срок оценки: Baseline, day 3, day 7, day 14, day 21, day 28]
• Change in Pain Relief/Satisfaction (ASA) [Срок оценки: Baseline, day 3, day 7, day 14, day 21, day 28]
• Wound Area Reduction Rate [Срок оценки: Day 7, day 14, day 28]
• Scar Assessment [Срок оценки: Month 1, month 3, month 6]
• Wound Recurrence Rate [Срок оценки: Proportion of participants experiencing recurrence of a wound at the same anatomical site within 6 months after complete healing.]
• Functional Recovery - Local Sensory Function [Срок оценки: 6 months after enrollment]
• Functional Recovery - Sweating Function [Срок оценки: 6 months after enrollment]

Критерии участия

Критерии включения

• Presence of any of the following wound types: acute wounds (burns, trauma, surgical incisions, skin avulsions), chronic wounds (diabetic foot ulcers, pressure injuries, venous ulcers, radiation ulcers, burn residual wounds), post-grafting wounds (autograft or allograft, including donor and recipient sites), or sutured wounds (postoperative incisions, flap surgery, tension-reducing sutures).
• 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 wound treatment.
• Willing to participate and able to provide signed informed consent.

Критерии исключения

• Active malignant tumor involving the wound area.
• Severe systemic infection or sepsis.
• Severe immunodeficiency or long-term use of high-dose corticosteroids.
• Intolerance to plasma therapy or refusal to participate.
• Pregnancy or breastfeeding.

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: NCT07553689 · hzc-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗