BioGlue or Vivostat in the Control of Air Leak in Thoracic Surgery

Not Applicable

Completed

• Conditions: Thoracic Surgery; Air Leak
• Interventions: Other: Vivostat; Other: BioGlue

• Registration Number: NCT00927342
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2009-06
• Study First Submitted: 2009-06-22
• Study First Submitted QC: 2009-06-23
• Last Update Submitted: 2009-06-23
• Study First Posted: 2009-06-24
• Last Update Posted: 2009-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Adults (18 years and over)
• Males and females
• Patients undergoing any thoracic surgical procedure likely to result in alveolar air leak.
• Written informed consent

Exclusion Criteria

• Age less than 18 years
• Pregnancy
• Breast feeding
• Previous treatment with BioGlue or Vivostat
• Inability to give informed consent
• Pneumonectomy
• Empyema
• Grade 0 air leak

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vivostat	Vivostat	-
BioGlue	BioGlue	-

Primary Outcome Measures

Name	Time	Method
Duration of air leak	Days post-operatively
Duration of intercostal drainage	Days post-operatively
Duration of hospital stay	Days post-operatively

Secondary Outcome Measures

Name	Time	Method
Post-operative complications	Days and weeks following discharge

Trial Locations

Locations (1)

Department of Thoracic Surgery, The Royal Brompton Hospital; 🇬🇧 London, United Kingdom