NCT05974228尚未招募不适用
Bioglass Wound Dressing in Treatment of Chronic Wound in Different Stage：a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- 2-week reduction rate of wound area
研究概览
简要总结
The goal of this randomized control trial is to test the efficacy and safety of a bioglass wound dressing in patients with chronic wound in different stages. The main question it aims to answer are:
- Whether the bioglass wound dressing have better efficacy and safety than blank control in treatment of chronic wound in necrosis stable stage？
- Whether the bioglass wound dressing have better efficacy and safety than blank control in treatment of chronic wound in granulation growth stage？ Participants will be assigned with a 1:1 ratio into intervention group and control group.
Participants of intervention group will receive bioglass wound dressing in addition with clinical optimal treatment plan. Participants of control group will only receive clinical optimal treatment plan.
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 is aged 18-80 years old;
- •Ulcerative wounds;
- •In the stage of stable necrosis or granulation growth;
- •Voluntarily participate in this study and sign an 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;
- •Uncontrolled blood glucose, Glucose test#Fasting blood sugar>15mmol/L, Glycated hemoglobin>12%;
- •There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented;
- •Serum albumin < 20 g/L; Hemoglobin<60 g/L; Platelets<50 × 10^9/L;
- •Spreading infection status, currently or about to be treated with antibiotics;
- •Patients with advanced malignant tumors;
- •Active period of autoimmune diseases;
- •Previous allergies to bioactive glass ointment dressings (self originating);
- •The patient is unable to cooperate or has mental disorders;
- •According to the judgment of the researcher, the subject has a clear reason that cannot be removed and affects wound healing, which is not suitable for this study or cannot comply with the requirements of this study.
结局指标
主要结局
2-week reduction rate of wound area
时间窗: 2-week
次要结局
- 2-week wound healing rate(2-week)
研究者
Long Zhang
Professor
Peking University Third Hospital
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