Comparative Assessment of Chitosan-Based Dressing, Ankaferd and Tranexamic Acid in Achieving Hemostasis and Healing Following Dental Extraction in Liver Pre-Transplant Children
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases
研究概览
简要总结
The aim of the present study is:
To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases where the:
• Primary objective: is to evaluate which of the previous materials will be the most effective as a hemostatic agent
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with end stage liver disease that need dental extraction before liver transplant
- •Patients aged between 4 and 9 years old
- •Patients having international normalized ratio (INR) values ≤ 4 (i.e. 1-4)
排除标准
- •Patients with allergy to sea food because chitosan- based dressing is manufactured from freeze-dried chitosan, derived from shrimp shell.
- •Patients having genetic bleeding disorders
- •Patients with renal diseases
研究组 & 干预措施
group 1 sterile gauze with chitosan
Chitosan-based dressing gauze after extraction in patients with end stage liver disease
干预措施: Chitosan (Drug)
group 2 sterile gauze with ankaferd blood stopper
ankaferd blood stopper dressing gauze after extraction in patients with end stage liver disease
干预措施: Ankaferd Blood Stopper (Drug)
group 3 sterile gauze with tranexamic acid
tranexamic acid dressing gauze after extraction in patients with end stage liver disease
干预措施: tranexamic acid (Drug)
结局指标
主要结局
To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases
时间窗: 30 minutes
evaluation of the previous materials which will be the most effective as a hemostatic agent by measuring blood loss after dental extraction after 30 minutes by the weight difference between the gauze preoperatively and postoperatively using fine electronic measurement weight device
次要结局
- pain score assessment(7 days)