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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00927342
Other study ID # 2005LS001B
Secondary ID
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


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
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