Dry Versus Moist Ag Dressings for Local Wound Infections: A Randomized Controlled Trial on Effectiveness and Cost-Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- wound area reduction in two weeks
研究概览
简要总结
This study aims to explore the differences in efficacy and cost-effectiveness between self-adhesive soft polysilicone silver ion foam dressings and traditional silver dressings in local infected wounds through a prospective randomized controlled study. The goal is to provide evidence-based medical support for clinical application, further shorten the wound healing time, and reduce the economic burden on the medical system and patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient's age ranges from 18 to 80 years old.
- •According to the IWII wound infection staging, infected wounds are classified as local infections*.
- •The wound type is ulcer, with an ulcer area ranging from 1 to 40 cm².
- •The wound stage is in the necrosis stabilization phase, granulation growth phase, or epithelial crawling phase**.
- •Voluntary participation in this study and signing the informed consent form
排除标准
- •Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;
- •The blood sugar level of diabetes is out of control, with fasting blood sugar > 15 mmol/L and glycosylated hemoglobin ≥ 10%;
- •There is active bleeding in the wound, and the conventional basic treatment plan cannot be implemented;
- •Serum albumin < 20 g/L; hemoglobin < 60 g/L; platelets < 50 × 109/L;
- •Disseminated infection or systemic infection state, and antibiotics are being used or will be used for treatment;
- •Patients with advanced malignant tumors;
- •The patient is in the active stage of autoimmune diseases;
- •The patient has previously been allergic to self-adhesive soft polysilicone silver ion foam dressings (Meipikang Silver) or Anxidean Nano Silver Trauma Patch;
- •The patient cannot cooperate or has a mental disorder;
- •According to the investigator's judgment, the subject has clear reasons that affect wound healing and is not suitable for this study or cannot comply with the requirements of this study.
研究组 & 干预措施
MOIST Ag dressing
Using MepilexAg in conjunction with conventional clinical treatments
干预措施: Ag foam dressing named MepilexAg (Device)
Dry Ag dressing
Using dry Ag dressing in conjunction with conventional clinical treatments
干预措施: Dry Ag dressing (Device)
结局指标
主要结局
wound area reduction in two weeks
时间窗: From enrollment to the end of treatment at 2 weeks
Pre-treatment area minus post-treatment area, then divided by pre-treatment area
次要结局
- wound healing rate(From enrollment to the end of treatment at 2 weeks)
研究者
Long Zhang
Head of Wound Healing Center
Peking University Third Hospital