NCT00707564撤回不适用
A Randomized, Self-Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing in a Population Treated With Anticoagulant Medications
HemCon Medical Technologies, Inc4 个研究点 分布在 1 个国家开始时间: 2008年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Time to hemostasis
研究概览
简要总结
The purpose of this study is to determine if the HemCon Dental Dressing is effective in stopping bleeding during dental surgeries in patients taking anticoagulant medications.
详细描述
As the HemCon® Dental Dressing has been FDA cleared for use as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief, the proposed study will further investigate the safety and efficacy of hemostasis of the dressing for use in dental surgical procedures that do not require primary closure (suturing) such as tooth extractions. This protocol will specifically research the safety and efficacy of hemostasis within a population of subjects taking anticoagulant medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are currently taking oral anticoagulant medications and eligible for surgery following standards of care
- •Patients requiring a minimum of 2 tooth extraction procedures.
- •Index pairing must reflect anatomically similar extraction locations
- •14 years of age or older
- •Available for a minimum of one post operative evaluation approximately 7 days post surgery
- •Extraction sites do not require primary closure or suturing
- •Willingness and ability to provide informed consent/ assent
排除标准
- •Scheduled to undergo a procedure other than tooth extractions
- •In the Investigators opinion, dental surgery may pose a serious risk of uncontrollable bleeding due to anticoagulant use
- •Scheduled to undergo 2 extractions, anatomically dissimilar
- •Extraction procedures are expected to require primary closure or suture
- •Unwilling or unable to provide informed consent/ assent
- •Patients undergoing bisphosphonate therapy
- •Patients not under current treatment with an oral anticoagulant medication
- •Patients who have discontinued the use of anticoagulant medications for a minimum of 3 days prior to the planned surgical visit
结局指标
主要结局
Time to hemostasis
时间窗: minutes after application
次要结局
- Incidence of post surgical sequela(1 week post surgery)
研究者
研究点 (4)
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