Neoveil® Versus TachoSil® for the Treatment of Pulmonary Air Leaks Following Lung Operation

Study Overview
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Brief Summary
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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.

Official Title
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Neoveil® Versus TachoSil® for the Treatment of Pulmonary Air Leaks Following Lung Operation

Conditions
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Prolonged Air Leak, Postoperative Air Leak

Intervention / Treatment
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* Other: TachoSil®
* Other: Neoveil®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TachoSil®<br>TachoSil® is a collagen sponge coated with the human coagulation factors fibrinogen and thrombin. | Other: TachoSil®<br>* topical absorbable fibrin sealant patch applied directly on the lung area with air fistula.<br>|
| Active Comparator: Neoveil®<br>Neoveil® sheet made of polyglycolic acid (PGA). It is a biodegradable, thermoplastic and non-antigenic polymer. | Other: Neoveil®<br>* bioabsorbable soft-tissue reinforcement material applied on the normal shape of the lung at the end of the operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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) | assessed at 10th postoperative day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drainage time, lung resection, TachoSil®, Neoveil®, air leak closure