NCT03479463终止不适用
A Matched Case Clinical Registry - Efficacy of AmnioFix in the Prevention of Post-Operative Salivary Leaks Following Head and Neck Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Incidence of Pharayngocutaneous Fistula Development (PCF)
研究概览
简要总结
This trial aims to determine if intra-operative use of human dehydrated amnion chorion allograft improves post-operative patient healing outcomes.
详细描述
This study is to determine if intra-operative use of Amnio-Fix improves post-operative patient healing outcomes after laryngectomy and/or pharyngectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
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
- •Subject is scheduled to undergo laryngectomy and/or pharyngectomy procedure due to oncological indication
- •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
- •Subjects currently enrolled in or planning to enroll in another clinical trial
- •Subjects with a known history of poor compliance with medical treatments
- •Subjects that are using or have used an investigational drug, device, or biologic within the 12 weeks prior to treatment
- •Subjects that have any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
- •Subject has undergone previous pharyngeal reconstructive surgery
- •Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
结局指标
主要结局
Incidence of Pharayngocutaneous Fistula Development (PCF)
时间窗: 60 days
Incidence of PCF developement necessitating intervention within the 60 day time point.
次要结局
未报告次要终点
研究者
研究点 (1)
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