NCT03108365已完成不适用
Evaluating the Effectiveness of Axiostat Hemostatic Dressing Material Versus Conventional Method of Hemostasis and Healing of Extraction Wounds in Patients on Oral Anti-Platelet Drugs - A Comparative Study
Axio Biosolutions Pvt. Ltd.0 个研究点目标入组 40 人开始时间: 2014年12月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Time to achieve haemostasis
研究概览
简要总结
The rationale of this study was to evaluate the efficacy of Axiostat hemostatic dental dressing in achieving hemostasis post-extraction and determining its effect on pain and healing of the extraction wound, compared to control, i.e. conventional method of extraction in patients on oral anti-platelet therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing multiple tooth extractions aged b/w 35- 70 years and with INR values ≤ 3.5 (1-3.5)
- •If present, sugar level should be under control
排除标准
- •Patients undergoing a single tooth or multiple extractions in same quadrant; and those with an allergy to seafood.
研究组 & 干预措施
Axiostat
Experimental
Size: 1 x 1 cm
Chitosan based haemostatic dressing
干预措施: Axiostat (Device)
Cotton Gauze
Active Comparator
Size: 1 x 1 cm
干预措施: Cotton Gauze (Device)
结局指标
主要结局
Time to achieve haemostasis
时间窗: 1 Day
Time to achieve hemostasis by observing the time at which blood oozing through or from periphery of the dressing stops.
次要结局
- Pain & Healing Scale(Upto 1 Day)
研究者
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