Prolonged Air LeakNCT04065880
Neoveil® Versus TachoSil® for the Treatment of Pulmonary Air Leaks Following Lung Operation
A study testing TachoSil® and Neoveil® in people with Prolonged Air Leak and Postoperative Air Leak, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Postoperative prolonged air leak (PAL), referring to the passage of air from the lung parenchyma into the pleural space, is one of the most frequent postoperative complications after lung resection. To control air leak, there are two different products certified since years: TachoSil® and Neoveil®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolonged Air Leak, Postoperative Air Leak
- What is being tested?
- TachoSil® and Neoveil®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2020to 31 Jul 2021
- 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
- Patients with a pulmonary air leak following open lung surgery, regardless of whether an anatomical or atypical resection was performed
- Patients who are able to decide for themselves whether to participate in the study or not ( for example due to language problems, mental disorders, dementia of the participant)
- Patients who are not family member or employee of the investigator
Who cannot join
- Inability to follow the procedures of the study, for example, due to language problems, mental disorders, dementia of the participant
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Thoracic Surgery, University Hospital Basel
Basel, 4031
About this study
Postoperative prolonged air leak (PAL), referring to the passage of air from the lung parenchyma into the pleural space, is one of the most frequent postoperative complications after lung resection. To control air leak, there are two different products certified since years: TachoSil® and Neoveil®. This study is to investigate the difference of TachoSil® and Neoveil® in patients with PAL.
- Conditions
- Prolonged Air Leak, Postoperative Air Leak
- Being tested
- TachoSil®, Neoveil®
- Keywords
- lung resection, TachoSil®, Neoveil®, air leak closure, drainage time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TachoSil®Other
topical absorbable fibrin sealant patch applied directly on the lung area with air fistula.
Neoveil®Other
bioabsorbable soft-tissue reinforcement material applied on the normal shape of the lung at the end of the operation.
| Study group | Role | What they receive |
|---|---|---|
| TachoSil® | Active comparator | TachoSil® is a collagen sponge coated with the human coagulation factors fibrinogen and thrombin. Receives: Other: TachoSil® |
| Neoveil® | Active comparator | Neoveil® sheet made of polyglycolic acid (PGA). It is a biodegradable, thermoplastic and non-antigenic polymer. Receives: Other: Neoveil® |
What is being measured
The primary outcome is the main question the study is designed to answer.
time required till air leak closure has occurred (hours)
time interval between end of the operation (closure of the skin) and air leak closure (less than 30ml on the digitalized drainage system).
Measured: end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day)
Secondary outcomes (3)
Incidence of air leak (binary outcome 0/1), i.e. air loss > 30ml
Incidence of air leak (binary outcome 0/1), i.e. air loss > 30ml
Measured: end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day)
Intensity of air leak (continuous outcome, ml)
Intensity of air leak (continuous outcome, ml)
Measured: end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day)
Incidence of prolonged air leak (>10 days) (binary outcome 0/1)
Incidence of prolonged air leak (>10 days) (binary outcome 0/1)
Measured: assessed at 10th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start1 Apr 2020
- Primary completion1 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prolonged Air LeakStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier Lardinois, Prof. MD, Principal investigator, Department of Thoracic Surgery, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065880
- Sponsor's protocol ID
- 2019-01505; ch19Lardinois
- Other IDs
- 2019
- Status last verified
- May 2023
- First submitted
- 20 Aug 2019
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bachmann H, Dackam SVC, Hojski A, Jankovic J, Vogt DR, Wiese MN, Lardinois D. Neoveil versus TachoSil in the treatment of pulmonary air leak following open lung surgery: a prospective randomized trial. Eur J Cardiothorac Surg. 2022 Dec 2;63(1):ezad003. doi: 10.1093/ejcts/ezad003.
PubMed 36651370
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoveil® Versus TachoSil® for the Treatment of Pulmonary Air Leaks Following Lung Operation
- ClinicalTrials.gov ID
- NCT04065880
- Acronym / sponsor ID
- 2019-01505; ch19Lardinois
- Conditions
- Prolonged Air Leak, Postoperative Air Leak
- Keywords
- lung resection, TachoSil®, Neoveil®, air leak closure, drainage time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 22 Aug 2019 (actual)
- 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.
Postoperative prolonged air leak (PAL), referring to the passage of air from the lung parenchyma into the pleural space, is one of the most frequent postoperative complications after lung resection. To control air leak, there are two different products certified since years: TachoSil® and Neoveil®. This study is to investigate the difference of TachoSil® and Neoveil® in patients with PAL.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TachoSil® | Active comparator | Other: TachoSil®TachoSil® is a collagen sponge coated with the human coagulation factors fibrinogen and thrombin. |
| Neoveil® | Active comparator | Other: Neoveil®Neoveil® sheet made of polyglycolic acid (PGA). It is a biodegradable, thermoplastic and non-antigenic polymer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a pulmonary air leak following open lung surgery, regardless of whether an anatomical or atypical resection was performed
- Patients who are able to decide for themselves whether to participate in the study or not ( for example due to language problems, mental disorders, dementia of the participant)
- Patients who are not family member or employee of the investigator
Key exclusion criteria (2 listed)
- Inability to follow the procedures of the study, for example, due to language problems, mental disorders, dementia of the participant
- Enrolment of the investigator, his/her family members, employees and other dependent persons
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 |
|---|---|---|
| TachoSil®topical absorbable fibrin sealant patch applied directly on the lung area with air fistula. | Other | TachoSil® |
| Neoveil®bioabsorbable soft-tissue reinforcement material applied on the normal shape of the lung at the end of the operation. | Other | Neoveil® |
Primary outcome
time required till air leak closure has occurred (hours)
Time frame: end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day)
time interval between end of the operation (closure of the skin) and air leak closure (less than 30ml on the digitalized drainage system).
3 secondary outcomes
Incidence of air leak (binary outcome 0/1), i.e. air loss > 30ml
Time frame: end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day)
Intensity of air leak (continuous outcome, ml)
Time frame: end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day)
Incidence of prolonged air leak (>10 days) (binary outcome 0/1)
Time frame: assessed at 10th postoperative day
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 15 May 2023.
- Results publication: PubMed 36651370Bachmann H, Dackam SVC, Hojski A, Jankovic J, Vogt DR, Wiese MN, Lardinois D. Neoveil versus TachoSil in the treatment of pulmonary air leak following open lung surgery: a prospective randomized trial. Eur J Cardiothorac Surg. 2022 Dec 2;63(1):ezad003. doi: 10.1093/ejcts/ezad003.
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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.
Didier Lardinois, Prof. MD principal investigator
Department of Thoracic Surgery, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TachoSil® and Neoveil® in people with Prolonged Air Leak and Postoperative Air Leak, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 inclusion and 2 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 15 May 2023. 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 Switzerland. 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?
time required till air leak closure has occurred (hours) (time frame: end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04065880, which also lists 1 linked publication.
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 15 May 2023.