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OpenTrials
Completed

NCT Number: NCT00927342

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.

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Key information

Conditions

Thoracic Surgery Air Leak

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Thoracic Surgery, The Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vivostat

Other

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

Other

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

Primary outcomes

  1. Duration of air leak

    Time frame: Days post-operatively

  2. Duration of intercostal drainage

    Time frame: Days post-operatively

  3. Duration of hospital stay

    Time frame: Days post-operatively

Secondary outcomes

  1. Post-operative complications

    Time frame: Days and weeks following discharge

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jun 24, 2009
Registry last updated
Jun 24, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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