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临床试验/NCT00927342
NCT00927342已完成不适用

A Comparison of BioGlue and Vivostat in the Prevention of Air Leak in Thoracic Surgery

Royal Brompton & Harefield NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2005年12月最近更新:
适应症

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

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)

研究者

研究点 (2)

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