ACTRN12620001266954尚未招募4 期
A multi-centre prospective randomised controlled trial to evaluate the efficacy and safety of a synthetic haemostatic gel (PuraStat) for bleeding prevention post endoscopic nasal surgery
RPA Institute of Academic Surgery0 个研究点目标入组 209 人开始时间: 2020年11月25日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 209
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Participants must meet all of the following criteria:
- •1. Patients suffering from a condition requiring endoscopic nasal turbinate reduction either by powered submucosal resection or turbinectomy
- •2. Patients undergoing a bilateral and symmetrical surgery
排除标准
- •Participants must not meet any of the following criteria:
- •1. Patients undergoing an asymmetrical or unilateral procedure
- •2. Patients undergoing a medial maxillectomy
- •3. Patients on anticoagulation or dual antiplatelet therapy
- •4. Patients with known coagulation system disorders
- •5. Patients suffering from spontaneous nasal bleeding
- •6. Patients with intra-operative arterial bleeding
- •7. Patients believed to have an allergic response to RADA 16 or oxidised regenerated cellulose
- •Patients who required return to theatre and further haemostasis to a site where PuraStat was applied in the first 24 hours will be excluded from the study population for secondary endpoint comparison
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