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

Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927342
• Other study ID #: 2005LS001B
• Status: Completed
• Phase: N/A
• First received: June 22, 2009
• Last updated: June 23, 2009
• Start date: December 2005
• Est. completion date: December 2007

Study information

• Verified date: June 2009
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Air Leak
• Thoracic Surgery

Intervention

Other:
• 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

Locations

Country	Name	City	State
United Kingdom	Department of Thoracic Surgery, The Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of air leak		Days post-operatively	No
Primary	Duration of intercostal drainage		Days post-operatively	No
Primary	Duration of hospital stay		Days post-operatively	No
Secondary	Post-operative complications		Days and weeks following discharge	No