BioGlue or Vivostat in the Control 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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||A Comparison of BioGlue and Vivostat in the Prevention of Air Leak in Thoracic Surgery|
- Duration of air leak [ Time Frame: Days post-operatively ] [ Designated as safety issue: No ]
- Duration of intercostal drainage [ Time Frame: Days post-operatively ] [ Designated as safety issue: No ]
- Duration of hospital stay [ Time Frame: Days post-operatively ] [ Designated as safety issue: No ]
- Post-operative complications [ Time Frame: Days and weeks following discharge ] [ Designated as safety issue: No ]
|Study Start Date:||December 2005|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
|Active Comparator: Vivostat||
Patients with an air leak at the end of thoracic surgery despite conventional measures(diathermy, suturing and/or stapling) will receive Vivostat sealant applied to the surface of the lung in an attempt to eliminate air leak
|Active Comparator: BioGlue||
Patients with an air leak at the end of thoracic surgery despite conventional measures(diathermy, suturing and/or stapling) will receive Bioglue sealant applied to the surface of the lung in an attempt to eliminate air leak
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927342
|Department of Thoracic Surgery, The Royal Brompton Hospital|
|London, United Kingdom, SW3 6NP|