Hemopatch Compared to TachoSil in Postoperative Air Leak Duration After Pulmonary Resection

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Controlled, Non-inferiority Study to Evaluate the Efficacy and Safety of Hemopatch Compared to TachoSil in Preventing or Reducing Postoperative Air Leaks After Pulmonary Resection

Conditions
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Air Leak From Lung

Intervention / Treatment
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* Device: Hemopatch
* Device: Tachosil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preoperative- Patients, 18 years or older at the time of signing the informed consent form (ICF), undergoing elective pulmonary resections (lobectomy, segmentectomy, or wedge resection), either through open thoracotomy or through Visually Assisted Thoracotomy surgery (VATS) Patients or legally authorized representatives, who are able to give IC after an explanation of the proposed study, and who are willing to comply with the study requirements for therapy during the entire study treatment period If female of child-bearing potential, patient will present with a negative blood/urine pregnancy test, and will agree to employ adequate birth control measures for the duration of the study Intraoperative- Patients with grade 1 or 2 (Macchiarini scale) air leakage after primary stapling and limited suturing Exclusion Criteria: Preoperative- Patients who had previous lung surgery (on the same side) Patients with an active, florid infection Patients who have received chemotherapy within the previous 3 weeks. Patients who have received radiation therapy within the previous 4 weeks. Patients with known hypersensitivity to the components of the investigational product and control (human fibrinogen, human thrombin, collagen of any origin, NHS-PEG) Patients undergoing emergency surgery Female patients of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period Female patients who are nursing Patients with exposure to another investigational drug or device clinical trial within 30 days prior to enrollment or anticipated in the 30 day study period till the End of study visit. Patient has a clinically significant concurrent medical condition (e.g. concomitant illness, drug/alcohol abuse) that, in the opinion of the investigator, could adversely affect patient's safety and/or compliance with study procedures Patient is a family member or employee of the investigator Intraoperative- Patients with serious complications during surgery, including the need for adhesiolysis, and pneumonectomy. Patients who were treated with any surgical sealant Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure Patients with any other intraoperative findings identified by the surgeon that may preclude the conduct of the study procedure

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemopatch<br>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. | Device: Hemopatch<br>* 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.<br>|
| Active Comparator: TachoSil<br>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. | Device: Tachosil<br>* Applied according to the current instruction for use (IFU).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of postoperative air leakage |  | Day 1 to Day 30 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |