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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TachoSil® | Active Comparator | TachoSil® is a collagen sponge coated with the human coagulation factors fibrinogen and thrombin. |
|
| Neoveil® | Active Comparator | Neoveil® sheet made of polyglycolic acid (PGA). It is a biodegradable, thermoplastic and non-antigenic polymer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TachoSil® | Other | topical absorbable fibrin sealant patch applied directly on the lung area with air fistula. |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Didier Lardinois, Prof. MD | Department of Thoracic Surgery, University Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Thoracic Surgery, University Hospital Basel | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36651370 | Result | 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. |
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| ID | Term |
|---|---|
| C518955 | TachoSil |
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Blinded participants and unblinded investigators and evaluators
| Neoveil® | Other | bioabsorbable soft-tissue reinforcement material applied on the normal shape of the lung at the end of the operation. |
|
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 |