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

This study has been completed.
Sponsor:
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00927342
First received: June 22, 2009
Last updated: June 23, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention
Thoracic Surgery
Air Leak
Other: Vivostat
Other: BioGlue

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Post-operative complications [ Time Frame: Days and weeks following discharge ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: December 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vivostat 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
Active Comparator: BioGlue Other: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927342

Locations
United Kingdom
Department of Thoracic Surgery, The Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Professor P Goldstraw, Department of Thoracic Surgery, Royal Brompton Hospital, London UK
ClinicalTrials.gov Identifier: NCT00927342     History of Changes
Other Study ID Numbers: 2005LS001B
Study First Received: June 22, 2009
Last Updated: June 23, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Air leak
Thoracic Surgery
Sealants

ClinicalTrials.gov processed this record on September 22, 2014