NCT06715696已完成不适用
Clinical Hemostatic Effectiveness of PET-Collagen Gauze ("HANBIO" Gauze) for Acute Wound: a Prospective, Single-arm, Open-label Evaluation Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Average Time(sec) to achieve hemostasis
研究概览
简要总结
The objective of this study is to collect the hemostatic effectiveness and device safety data of "HANBIO" Gauze in subjects have acute wound result from gynecology surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female between 20 and 70 years of age.
- •Subject scheduled for a non-emergent, gynecological surgery.
- •Subject has an identified bleeding site/area intraoperatively.
- •Subject is willing to comply with all aspects of the study and have signed informed consent form.
排除标准
- •Pregnant or lactating female.
- •The wound is chronic wound that not healed within 8 weeks, e.g. ulcers.
- •The wound is caused by radiation or burns.
- •Subject is sensitive or allergic to collagen.
- •Subject is sensitive or allergic to polyester (PET).
- •Subject has medical history of coagulation disorder or disease (e.g., hemophilia, thrombocytopenia).
- •Subject receives anticoagulants or antiplatelets.
- •Subject plans to receive other hemostatic gauze/dressing/agent/medical device as primary hemostasis.
- •Subject has participated in another clinical trial within the past 30 days.
- •Subjects with any pre-operative or intra-operative findings that may preclude conduct of the study procedure or unable to evaluate the outcomes.
结局指标
主要结局
Average Time(sec) to achieve hemostasis
时间窗: 3 min
The mean time(seconds) required to achieve hemostasis following the application of "HANBIO" Gauze.
次要结局
- Proportions of subjects achieving hemostatic success at 3 min.(3 min)
- Number/proportion of adverse and serious adverse events.(3 min)
- Ease of use questionnaire of Product "HANBIO" Gauze (by Principal Investigator)(3 min)
研究者
研究点 (1)
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