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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
279
Baxter Investigational Site
Catania, Italy
Baxter Investigational Site
Milan, Italy
Baxter Investigational Site
Padua, Italy
Duration of postoperative air leakage
Time frame: Day 1 to Day 30
Incidence of intraoperative treatment failure
Time frame: Day 1
Incidence of patients with prolonged air leakage defined as air leakage > 5 Days
Time frame: Day 5 to Day 30
Number of additional procedures needed
Type of procedures include chest drainage, re-operation, respiratory assistance, and blood transfusion
Time frame: Day 1 to Day 30
Time to chest tube removal
Time frame: Day 1 to Day 30
Time in surgery (minutes) from incision to closure
Time frame: Day 1
Length of stay in hospital (days)
Time frame: Day 1 to Day 30
Number of unplanned interventions
Time frame: 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
Time frame: Day 1 to Day 30
Number of patches used intra-operatively
Time frame: Day 1
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Baxter Investigational Site
Pisa, Italy
Baxter Investigational Site
Rome, Italy
Baxter Investigational Site
Rome, Italy
Baxter Investigational Site
Rome, Italy
Baxter Investigational Site
Seville, Andalusia, Spain
Baxter Investigational Site
Madrid, Getafe, Spain
Baxter Investigational Site
Madrid, Madrid, Spain
...and 4 more locations