Randomized Medico-economic Assessment of Preventive Devices Used for Post-operative Hemorrhagic Risk in Endonasal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 571
- 主要终点
- Per-operative hemostasis
研究概览
简要总结
This study evaluates the efficiency and the cost of three medical devices and the abstention of the use of specific product for the post-operative haemostasis in endonasal surgery .
详细描述
Surgiflo® is a matrix of haemostatic frost of porcine protein origin is the coverage of the post-operative bleeding of which one of the indications is in endonasal surgery.
Floseal® is a haemostatic frost(gel) containing of the thrombin.
Algosteril® is a lint tent of arginate of calcium.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •endonasal surgery schedule
- •Surgical indications:
- •hypertrophic rhinitis, repeated or chronic infections, extraction of foreign body, polyposes naso-sinusal, benign tumors limited to the nasal pit and in sine,
排除标准
- •Pregnant Woman
- •Disorder of the haemostasis known or disrupted preoperative biological balance assessment
- •Use of treatment disrupting the blood coagulation (anti platelet, anti vitamin K, AINS)
- •Unchecked HTA by the treatment and/or preoperative > mmHg 160/90
- •Surgical Act including a septoplasty
- •malignant tumoral surgical Indication, or mild overtaking the naso-sinusial system
- •Dacryocystorhinostomy
研究组 & 干预措施
Surgiflo
Using Surgiflo® (Absorbable Gelatin Hemostatic) for the post-operative haemostasis in endonasal surgery.
干预措施: Surgiflo (Device)
Floseal
Using Floseal® (Absorbable Gelatin Hemostatic) containing human thrombin for the post-operative haemostasis in endonasal surgery
干预措施: Floseal (Device)
Algosteril
Using Algosteril® (Hemostatic Sterile Wick) for the post-operative haemostasis in endonasal surgery
干预措施: Algosteril (Device)
Abstention
Not using device for the post-operative haemostasis in endonasal surgery
结局指标
主要结局
Per-operative hemostasis
时间窗: Hours 0
Time needs to observe hemostasis after the device set up
Hemostasis at the 24th hour
时间窗: Hours 24
* Algosteril arm (after having removed the wick): spontaneous observation of hemostasis in less that 3 min (yes/no) and needs to have a new intervention to stop bleedings (type) * Surgiflo, Floseal, Abstention arms: time to observe hemostasis if bleedings occurred.
Hemostasis in the 6 first hours
时间窗: Hours 6
Number of compresses used from Hours 0 to Hours 6.
Spontaneous hemorrhagic events
时间窗: from Hours 0 to Day 45
number of spontaneous hemorrhagic events.
次要结局
- Device evaluation by the surgeon(Hours 0)
- Preoperative assessment(Hours 0)