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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 主要终点
- Complete Wound Healing Rate at 4 Weeks
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 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.
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
- •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.
排除标准
- •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.
研究组 & 干预措施
Plasma Device Group
Patients receiving standard wound care plus plasma device therapy. The plasma device is applied to the wound bed at a distance of 5-10 mm for 3-10 minutes per session, once daily or every other day, until complete wound healing or suture removal.
干预措施: Plasma Device (Device)
Conventional Treatment Group
Patients receiving standard wound care alone, including wound bed preparation (debridement, infection control, moist healing, dressing changes). This group does not receive plasma device therapy. Patients may be derived from retrospective cases or concurrent non-plasma users, with confounding factors controlled by propensity score matching.
结局指标
主要结局
Complete Wound Healing Rate at 4 Weeks
时间窗: 4 weeks after enrollment
Proportion of wounds (acute wounds, post-grafting wounds, and sutured wounds) achieving complete epithelialization without drainage at 4 weeks post-treatment.
Proportion of Wounds Achieving ≥50% Area Reduction at 4 Weeks
时间窗: 4 weeks after enrollment
For chronic wounds (diabetic foot ulcers, pressure injuries, venous ulcers, radiation ulcers, etc.), the proportion of wounds showing a reduction in wound area of 50% or more compared to baseline at 4 weeks.
次要结局
- Time to Complete Wound Healing(From enrollment to complete epithelialization, assessed up to 6 months)
- Change in Pain Score (VAS)(Baseline, day 3, day 7, day 14, day 21, day 28)
- Change in Pain Relief/Satisfaction (ASA)(Baseline, day 3, day 7, day 14, day 21, day 28)
- Wound Area Reduction Rate(Day 7, day 14, day 28)
- Scar Assessment(Month 1, month 3, month 6)
- Wound Recurrence Rate(Proportion of participants experiencing recurrence of a wound at the same anatomical site within 6 months after complete healing.)
- Functional Recovery - Local Sensory Function(6 months after enrollment)
- Functional Recovery - Sweating Function(6 months after enrollment)
研究者
Hu Zhicheng
Professer
First Affiliated Hospital, Sun Yat-Sen University