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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003931-12 | EudraCT Number |
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This study is a randomized, controlled study, with the primary objective to demonstrate non-inferiority of Hemopatch compared to TachoSil in postoperative air leak duration after pulmonary resection, and with the secondary objective of evaluating the safety of Hemopatch compared to TachoSil.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemopatch | Experimental | Patients undergo elective pulmonary resection. Following resection, primary stapling and suturing will be done and air leakage will be assessed. If a specific grade-level of air leakage is present, patients will be randomized and either Hemopatch or TachoSil applied. |
|
| TachoSil | Active Comparator | Patients undergo elective pulmonary resection. Following resection, primary stapling and suturing will be done and air leakage will be assessed. If a specific grade-level of air leakage is present, patients will be randomized and either Hemopatch or TachoSil applied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemopatch | Device | Applied according to the current instruction for use (IFU). According to the IFU, a maximum of 7 Hemopatch 45 x 90 mm patches can be used in adults. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of postoperative air leakage | Day 1 to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intraoperative treatment failure | Day 1 | |
| Incidence of patients with prolonged air leakage defined as air leakage > 5 Days | Day 5 to Day 30 | |
| Number of additional procedures needed |
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Inclusion Criteria:
Preoperative-
Intraoperative-
Exclusion Criteria:
Preoperative-
Intraoperative-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baxter Investigational Site | Catania | 95123 | Italy | |||
| Baxter Investigational Site |
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| Tachosil | Device | Applied according to the current instruction for use (IFU). |
|
Type of procedures include chest drainage, re-operation, respiratory assistance, and blood transfusion |
| Day 1 to Day 30 |
| Time to chest tube removal | Day 1 to Day 30 |
| Time in surgery (minutes) from incision to closure | Day 1 |
| Length of stay in hospital (days) | Day 1 to Day 30 |
| Number of unplanned interventions | Day 1 to Day 30 |
| Incidence of pre-defined postoperative Adverse Events of Special Interest (AESIs) | Pre-defined AEs include Pneumothorax, Bronchopleural fistula, Emphysema (subcutaneous and mediastinal), Pleural effusions, Postoperative respiratory failure, Empyema, Allergic reactions in reasonable temporal relationship with the product application | Day 1 to Day 30 |
| Number of patches used intra-operatively | Day 1 |
| Milan |
| 20141 |
| Italy |
| Baxter Investigational Site | Padova | 35128 | Italy |
| Baxter Investigational Site | Pisa | 56124 | Italy |
| Baxter Investigational Site | Rome | 144 | Italy |
| Baxter Investigational Site | Rome | 151 | Italy |
| Baxter Investigational Site | Rome | 168 | Italy |
| Baxter Investigational Site | Seville | Andalusia | 41009 | Spain |
| Baxter Investigational Site | Madrid | Getafe | 28905 | Spain |
| Baxter Investigational Site | Madrid | Madrid | 28006 | Spain |
| Baxter Investigational Site | Madrid | Madrid | 28040 | Spain |
| Baxter Investigational Site | Madrid | Madrid | 28933 | Spain |
| Baxter Investigational Site | Alzira | Valencia | 46600 | Spain |
| Baxter Investigational Site | Madrid | 28046 | Spain |