Thoracic SurgeryNCT00927342
BioGlue or Vivostat in the Control of Air Leak in Thoracic Surgery
A study testing Vivostat and BioGlue in people with Thoracic Surgery and Air Leak, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Air Leak
- What is being tested?
- Vivostat and BioGlue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2005to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18 years and over)
- Males and females
- Patients undergoing any thoracic surgical procedure likely to result in alveolar air leak.
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Thoracic Surgery, The Royal Brompton Hospital
London, SW3 6NP
About this study
Official title: A Comparison of BioGlue and Vivostat in the Prevention 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.
Read more
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.
- Conditions
- Thoracic Surgery, Air Leak
- Being tested
- Vivostat, BioGlue
- Keywords
- Air leak, Thoracic Surgery, Sealants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VivostatOther
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
BioGlueOther
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
| Study group | Role | What they receive |
|---|---|---|
| Vivostat | Active comparator | Not described Receives: Other: Vivostat |
| BioGlue | Active comparator | Not described Receives: Other: BioGlue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of air leak
Measured: Days post-operatively
Duration of intercostal drainage
Measured: Days post-operatively
Duration of hospital stay
Measured: Days post-operatively
Secondary outcomes (1)
Post-operative complications
Measured: Days and weeks following discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startDec 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927342
- Sponsor's protocol ID
- 2005LS001B
- Status last verified
- Jun 2009
- First submitted
- 22 Jun 2009
- Last updated
- 24 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of BioGlue and Vivostat in the Prevention of Air Leak in Thoracic Surgery
- ClinicalTrials.gov ID
- NCT00927342
- Acronym / sponsor ID
- 2005LS001B
- Conditions
- Thoracic Surgery, Air Leak
- Keywords
- Air leak, Thoracic Surgery, Sealants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 24 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vivostat | Active comparator | Other: Vivostat |
| BioGlue | Active comparator | Other: BioGlue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (18 years and over)
- Males and females
- Patients undergoing any thoracic surgical procedure likely to result in alveolar air leak.
- Written informed consent
Key exclusion criteria (8 listed)
- Age less than 18 years
- Pregnancy
- Breast feeding
- Previous treatment with BioGlue or Vivostat
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VivostatPatients 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 | Other | Vivostat |
| BioGluePatients 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 | Other | BioGlue |
Primary outcome
Duration of air leak
Time frame: Days post-operatively
Duration of intercostal drainage
Time frame: Days post-operatively
Duration of hospital stay
Time frame: Days post-operatively
1 secondary outcome
Post-operative complications
Time frame: Days and weeks following discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivostat and BioGlue in people with Thoracic Surgery and Air Leak, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of air leak (time frame: Days post-operatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2009.