Neoveil® Versus TachoSil® for the Treatment of Pulmonary Air Leaks Following Lung Operation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- time required till air leak closure has occurred (hours)
研究概览
简要总结
Postoperative prolonged air leak (PAL), referring to the passage of air from the lung parenchyma into the pleural space, is one of the most frequent postoperative complications after lung resection. To control air leak, there are two different products certified since years: TachoSil® and Neoveil®. This study is to investigate the difference of TachoSil® and Neoveil® in patients with PAL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Blinded participants and unblinded investigators and evaluators
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 with a pulmonary air leak following open lung surgery, regardless of whether an anatomical or atypical resection was performed
- •Patients who are able to decide for themselves whether to participate in the study or not ( for example due to language problems, mental disorders, dementia of the participant)
- •Patients who are not family member or employee of the investigator
排除标准
- •Inability to follow the procedures of the study, for example, due to language problems, mental disorders, dementia of the participant
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
结局指标
主要结局
time required till air leak closure has occurred (hours)
时间窗: end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day)
time interval between end of the operation (closure of the skin) and air leak closure (less than 30ml on the digitalized drainage system).
次要结局
- Incidence of air leak (binary outcome 0/1), i.e. air loss > 30ml(end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day))
- Intensity of air leak (continuous outcome, ml)(end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day))
- Incidence of prolonged air leak (>10 days) (binary outcome 0/1)(assessed at 10th postoperative day)