The Evaluation of Topical Hemostatic Powder Containing Hydrophilic Polymer With Potassium Ferrate for Hemostasis Following Nail Surgery
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time (in seconds) to bleeding cessation with hydrophilic polymer and potassium ferrate; time (in seconds) to bleeding cessation with direct pressure with sterile gauze
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of topical hemostatic powder containing hydrophilic polymer with potassium ferrate for bleeding control after nail surgical procedures
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •At least 18 years old
- •Patients scheduled for any type of nail surgical procedure
- •Willingness to participate in the study
- •Ability to understand all instructions in the English language
排除标准
- •Failure to have nail surgery performed
- •Likely inability to comply with the study protocol or cooperate fully with the research team
研究组 & 干预措施
Hydrophilic polymer and potassium ferrate powder
Hydrophilic polymer with potassium ferrate powder is applied to the surgical wound with pressure until hemostasis is achieved
干预措施: Hydrophilic polymer and potassium ferrate powder (Device)
Direct pressure with sterile gauze
Direct pressure with sterile gauze is applied to the surgical wound until hemostasis is achieved
结局指标
主要结局
Time (in seconds) to bleeding cessation with hydrophilic polymer and potassium ferrate; time (in seconds) to bleeding cessation with direct pressure with sterile gauze
时间窗: Baseline
Time (in seconds) will be measured from application of intervention/nonintervention until bleeding cessation
次要结局
- Number of participants with at least one adverse event(End of study (28 days))
