Multicentric, Prospective, Controlled, Randomised Clinical Study of the Device Traumacel FAM Trium in the Post-market Surveillance Phase
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Number of subjects in whom haemostasis was achieved within 3 minutes after administration.
研究概览
简要总结
The investigational medical device Traumacel FAM Trium is a sterile plant polysaccharide haemostatic agent based on the oxidized cellulose in the form of multilayer nonwoven fabric. It is used as an adjunct to stop capillary, venous, or small arterial bleeding, and also to prevent early postoperative bleeding. It can be used in all areas of stopping diffuse bleeding from resection surfaces such as parenchymatous organs, muscles or defined body cavities. The wide scope of application allows the use for classical, robotic surgery and endoscopic treatments (e.g. laparoscopic).
The main objective of the study is to compare the efficacy and safety of Traumacel FAM Trium and regenerated oxidized cellulose based fibrous haemostat when used in accordance with their intended purpose. The partial objectives are: identification of any previously unknown side-effects and monitoring of known side-effects; identification and analysis of potentially newly emerging risks; confirmation of the acceptability of the benefit-risk ratio; identification of any systematic misuse of the device or off-label use of the device in order to verify the correctness of its intended purpose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum age of
- •Surgical intervention.
- •Negative pregnancy test of women in fertile age.
- •Diffuse soft tissue, vascular or parenchymal haemorrhage after conventional surgical haemostatic methods have not worked or are impractical (e.g. ligation, suture, compression, cauterisation).
- •Informed consent
排除标准
- •Hypersensitivity or a known reaction to oxidized cellulose.
- •Age under 18
- •A severe clinical condition of the patient (e.g. associated illness, mental disorder) which, according to the investigator, could adversely affect patient safety and/or compliance with the procedures used in the study.
- •The patient has participated in another clinical study involving a haemostatic product within 30 days prior to enrolment, or another such clinical study is planned during the subject's participation in the study.
- •Pregnancy or lactation.
- •If during the procedure itself, there was no need to use the test agent
- •Application of any other topical haemostatic product prior to application of the test agent to the same site.
结局指标
主要结局
Number of subjects in whom haemostasis was achieved within 3 minutes after administration.
时间窗: 3 minutes
Number of subjects who required surgical revision within 12 hours after the procedure for recurrent bleeding.
时间窗: 12 hours
Time required to achieve haemostasis.
时间窗: 10 minutes
次要结局
- Degree of bleeding from target bleeding site(10 minutes)
- Number of subjects with complications during surgery.(During a surgical procedure, an average of 1 hour)
- Number of subjects in whom haemostasis was achieved within 2 minutes after administration.(2 minutes)
- Occurrence of adverse events.(1 month)