NCT02668978已完成4 期
Prospective Randomized Clinical Trial to Prevent Air Leaks After Lung Resection With Hemopatch™ Sealing Hemostat: SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial
Quirón Madrid University Hospital2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2016年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Duration of postoperative air leaks
研究概览
简要总结
The primary objective is to assess the efficacy and safety of HEMOPATCH™ Sealing Hemostat in reducing the incidence and duration of air leaks after lung resection compared to standard techniques.
Hypothesis: "The routine application of HEMOPATCH Sealing Hemostat on the visceral pleura in lung resection areas, during lung resection procedures, is more EFFICIENT to reduce the incidence and duration of prolonged air leaks as compared to standard surgical measures."
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Patients over the age of 18 years who are able to give their informed consent
- •Patients undergoing lung resection surgery for either malignant or benign conditions including:
- •Lobar and sublobar resections
- •Open, video-assisted thoracoscopic or robotic surgeries
- •Diagnostic or therapeutic procedures
排除标准
- •Traumatic pulmonary contusion or laceration
- •Lung reduction surgery
- •Planned removal of more than 10 lung lesions
- •Pneumonectomy
- •Known hypersensitivity to bovine protein
- •Known hypersensitivity to Brilliant Blue FCF (E133)
- •Presence of active infection
结局指标
主要结局
Duration of postoperative air leaks
时间窗: Within first 30 postoperative days
Duration of postoperative lung air leaks expressed in hours
次要结局
未报告次要终点
研究者
Javier MORADIELLOS
Associate Chief of Thoracic Surgery
Quirón Madrid University Hospital
研究点 (2)
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