A Comparison of BioGlue and Vivostat in the Prevention of Air Leak in Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Duration of air leak
研究概览
简要总结
Following lung surgery air may continue to leak from the surface of the lung. Chest drains are placed to allow this air to be removed safely and prevent the lung from collapsing. Drains need to remain until the air leak from the lung has ceased.
Air which continues to leak results in longer chest drainage times which cause increased discomfort and immobility for patients. These patients are at risk of secondary complications such as infection. Longer hospital stays and increased costs ensue. A randomised controlled trial (RCT) conducted at The Royal Brompton Hospital has shown clear benefits in the management of difficult air leak with the use of BioGlue. BioGlue is a surgical sealant applied to the surface of the lung at the time of surgery.
BioGlue is of bovine origin. Concerns exist regarding the potential risk of transmission of blood borne diseases with bovine derived medical products. Should a surgical adhesive without these potential risks prove as effective as BioGlue then its use could be commended.
The Vivostat System is a medical system that derives a sealant from the patient's own blood. A small study has shown that it may also be of benefit in the management of difficult air leaks. The principal aim of our RCT is to compare the duration of air leak, length of chest drainage and hospital stay associated with BioGlue to that of Vivostat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Adults (18 years and over)
- •Males and females
- •Patients undergoing any thoracic surgical procedure likely to result in alveolar air leak.
- •Written informed consent
排除标准
- •Age less than 18 years
- •Pregnancy
- •Breast feeding
- •Previous treatment with BioGlue or Vivostat
- •Inability to give informed consent
- •Pneumonectomy
- •Grade 0 air leak
结局指标
主要结局
Duration of air leak
时间窗: Days post-operatively
Duration of intercostal drainage
时间窗: Days post-operatively
Duration of hospital stay
时间窗: Days post-operatively
次要结局
- Post-operative complications(Days and weeks following discharge)
