NCT04234321Unknown不适用
A Multicenter, Prospective Clinical Study of Kangfuxin and Basic Fibroblast Growth Factor in Promoting the Healing of Donor Site
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Wound healing rate
研究概览
简要总结
The main objective of this study is to observe whether basic fibroblast growth factor and Kangfuxin Liquid can promote the wound healing in the donor area and further evaluate the healing quality.
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
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male / female patients aged 20-50;
- •Burn area ≤ 30% TBSA;
- •Patients who need auto skin grafting due to burns or skin defects due to trauma;
- •The donor area is 100cm2, and the thickness of skin is 0.25mm (Split thickness skin donor site group)/0.40mm (Medium thickness skin donor site group). The donor site is the body part with similar skin color and sufficient skin area (except scalp);
- •Not involved in clinical trials of other drugs;
- •Subjects who have agreed to participate in the clinical study and signed the informed consent.
排除标准
- •Subjects who were previously allergic to similar products or related components of test products;
- •Subjects with other systemic or local skin diseases that may affect wound evaluation;
- •Subjects with significant organ dysfunction / failure or other serious diseases, including clinical related cardiovascular disease or myocardial infarction within 12 months before enrollment; malignant tumor; serious neurological or psychiatric history; serious infection; active disseminated intravascular coagulation;
- •Subjects with moderate malnutrition (BMI < 17kg / m2) and severe anemia (HB < 60g / L);
- •Subjects proposed to use immunosuppressant, steroid hormone, epidermal growth factor and other drugs that may affect the wound healing of the donor skin within 3 months before admission or during the study period;
- •Participated in clinical trials of any other drugs or medical devices within 3 months;
- •History of major diseases that may affect general physical condition and other patients who are not considered by the researchers to be eligible for this study.
研究组 & 干预措施
basic fibroblast growth factor
Experimental
Basic fibroblast growth factor,100ml/ bottle, (35000IU / 8ml) / 100cm2 / time,three times a day.
干预措施: basic fibroblast growth factor (Drug)
Kangfuxin Liquid
Experimental
Kangfuxin Liquid,20ml / 100cm2 / time,three times a day.
干预措施: Kangfuxin Liquid (Drug)
0.9% Normal saline
Placebo Comparator
0.9% Normal saline,20ml / 100cm2 / time,three times a day.
干预措施: 0.9% Normal saline (Drug)
结局指标
主要结局
Wound healing rate
时间窗: up to 2 or 3 weeks
Means (wound area before treatment - wound area after treatment) / wound area before treatment × 100%.
Actual healing time
时间窗: up to 2 or 3 weeks
Means time of complete wound healing
次要结局
- Degree of scar formation(up to 3 or 12 weeks)
研究者
研究点 (1)
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