NCT03479489已完成不适用
A Prospective Case Series for Closed Hemorrhoidectomy - Efficacy of External Hemorrhoid Repair Using a Dehydrated Human Amnion Chorion Membrane
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Reported Patient Pain
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of human dehydrated amnion chorion allograft in closed hemorrhoidectomy as assessed by patient and wound assessments.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of acutely thrombosed hemorrhoid or an external hemorrhoid exceeding 72 hours in duration
- •Subject is undergoing closed hemorrhoidectomy as their definitive treatment for the Grade 2-4 hemorrhoid
- •Subject is age 18 or older
- •Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
排除标准
- •Subject has a known history of poor compliance with medical treatments
- •Subject has signs and symptoms of active cirrhosis
- •Subject has signs and symptoms of Crohn's disease complicated by perianal manifestations
- •Subject is currently taking immunosuppressive medications
- •Subject has had previous surgery in the target area within the past 6 months prior to treatment or plans to have surgery other than closed hemorrhoidectomy in the target area within 180 days of treatment
- •Subject is currently receiving radiation therapy or chemotherapy
- •Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment
- •Subject is pregnant at enrollment or is planning to become pregnant within 180 days of treatment; subject intends to breastfeed during the course of the trial
- •Subject has any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
- •Subject has an allergy or known sensitivity to aminoglycoside antibiotics such as gentamicin sulfate and/or streptomycin sulfate
结局指标
主要结局
Reported Patient Pain
时间窗: 60 days
The primary endpoint of the study is the change in patient reported pain across four categories from baseline within the 60 day follow-up period. In every patient diary, subjects will be asked to assess their pain on a 10 point Likert scale under the following conditions * Do you experience pain continuously? * Do you experience pain with activity? * Do you experience pain while sitting? * Do you experience pain with bowel movements?
次要结局
未报告次要终点
研究者
研究点 (2)
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