Near-infrared FluORescencE Assessment of Myocutaneous Flap Microperfusion for Gynecologic RecONstrucTion (FOREFRONT): A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 14
- 主要终点
- Percentage of cases in which intraoperative ICG-NIR angiography altered surgical flap reconstruction plans
研究概览
简要总结
The objective of this study is to assess whether Near-Infrared Fluorescence/NIR Imaging perfusion alters intraoperative management of the flap or of the participant wound bed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing a pelvic reconstruction procedure after radical gynecologic surgery for any indication at MSK.
- •Age ≥18 years.
排除标准
- •Women with hepatic dysfunction as evidenced by elevated transaminases (two times the upper limit of normal).
- •Women with a history of cirrhosis or other chronic liver disease.
- •Women with a documented severe or life threatening allergy to iodine.
- •Women with an allergy to ICG or severe allergy to iodinated contrast.
- •Women undergoing any free flap (non-pedicled) reconstruction.
研究组 & 干预措施
Participants undergoing a pelvic or abdominal wall reconstruction procedure
Women undergoing a pelvic or abdominal wall reconstruction procedure after radical gynecologic surgery for any indication at Memorial Sloan Kettering Cancer Center
干预措施: ICG-NIR angiography (Diagnostic Test)
结局指标
主要结局
Percentage of cases in which intraoperative ICG-NIR angiography altered surgical flap reconstruction plans
时间窗: Up to 24 months
The primary purpose of this study is to introduce ICG-NIR angiography in abdominopelvic skin and myocutaneous pedicle flap-based reconstruction during gynecologic oncology surgery and determine the percentage of cases in which intraoperative ICG-NIR angiography altered surgical flap reconstruction plans.
次要结局
未报告次要终点