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

Study Overview
=================
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.

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

Conditions
-----------------
Thoracic Surgery, Air Leak

Intervention / Treatment
-----------------
* Other: Vivostat
* Other: BioGlue


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vivostat<br> | Other: Vivostat<br>* 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<br>|
| Active Comparator: BioGlue<br> | Other: BioGlue<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of air leak |  | Days post-operatively | 
| Duration of intercostal drainage |  | Days post-operatively | 
| Duration of hospital stay |  | Days post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative complications |  | Days and weeks following discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Air leak, Thoracic Surgery, Sealants