Thoracic Surgery Clinical Trial
Official title:
A Comparison of BioGlue and Vivostat in the Prevention of Air Leak in Thoracic Surgery
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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