BioGlue or Vivostat in the Control of Air Leak in Thoracic Surgery
NCT ID: NCT00927342
Last Updated: 2009-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
103 participants
INTERVENTIONAL
2005-12-31
2007-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Vivostat
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
BioGlue
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* Males and females
* Patients undergoing any thoracic surgical procedure likely to result in alveolar air leak.
* Written informed consent
Exclusion Criteria
* Pregnancy
* Breast feeding
* Previous treatment with BioGlue or Vivostat
* Inability to give informed consent
* Pneumonectomy
* Empyema
* Grade 0 air leak
18 Years
ALL
No
Sponsors
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Royal Brompton & Harefield NHS Foundation Trust
OTHER
Responsible Party
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Department of Thoracic Surgery, Royal Brompton Hospital, London UK
Locations
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Department of Thoracic Surgery, The Royal Brompton Hospital
London, , United Kingdom
Countries
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Other Identifiers
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2005LS001B
Identifier Type: -
Identifier Source: org_study_id
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