2025-524710-29-00招募中4 期
Comparing intraoperative indocyanine green fluorescence imaging with standard clinical assessment for flap perfusion in head and neck reconstruction: A randomised controlled Trial (VISION Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 244
- 试验地点
- 2
- 主要终点
- The primary endpoint is incidence of partial flap loss requiring surgical intervention within 1 month.
研究概览
简要总结
The primary objective is to compare the incidence of partial flap loss requiring surgical intervention within 1 month between patients undergoing intraoperative ICG angiography and those assessed using standard clinical methods.
研究设计
- 分配方式
- 随机
- 主要目的
- Intraoperative perfusion assessment period
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- To be included in the trial, subjects must meet all of the following criteria: 1) The subject is able to provide informed consent to the trial. 2) The subject is above 18 years of age. 3) The subject will undergo microvascular free flap reconstruction for oncologic or traumatic head and neck defects.
排除标准
- Subjects meeting any of the following criteria will be excluded: 1) The subject is allergic to indocyanine green or iodine 2) The subject has severe hepatic or renal impairment 3) The subject is pregnant
研究组 & 干预措施
Verdye 5 mg/ml pulver till injektionsvätska, lösning
Test
干预措施: Verdye 5 mg/ml pulver till injektionsvätska, lösning (Drug)
结局指标
主要结局
The primary endpoint is incidence of partial flap loss requiring surgical intervention within 1 month.
The primary endpoint is incidence of partial flap loss requiring surgical intervention within 1 month.
次要结局
- The secondary endpoints of this trial are total flap loss, flap related re-exploration rate in general anaesthesia and flap salvage rate within one month, and postoperative complications (graded according to the Clavien-Dindo classification) within three months.
研究者
研究点 (2)
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标识符
- 欧盟试验编号
- 2025-524710-29-00
日期
- 首次发布
- (4个月前)
- 研究完成日期
- (6年后)
- 最近更新
- (4个月前)
监管与共享
- 是否有结果
- 否
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