Postoperative air leakage MedDRA version: 20.0 Level: PT Classification code 10067826 Term: Pulmonary air leakage System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: TachoSil sealant matrix
Product Name: TachoSil
Pharmaceutical Form: Sealant matrix
INN or Proposed INN: HUMAN FIBRINOGEN
CAS
Sponsors
Baxter Healthcare Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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 Video-Assisted Thoracoscopic 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 111 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
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 - Patients on chronic use of steroids - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Hemopatch compared to TachoSil in postoperative air leak duration after pulmonary resection.;Secondary Objective: To evaluate the safety of Hemopatch compared to TachoSil in postoperative application after pulmonary resection.;Primary end point(s): The duration of postoperative air leakage, measured in days.;Timepoint(s) of evaluation of this end point: Postoperative air leakage will be assessed on the evening of the day of operation and subsequently at least twice daily (morning and evening) until chest drain removal. All patients will be followed up to 30 days postoperatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Incidence of intraoperative treatment failure - Incidence of patients with prolonged air leakage defined as air leakage > 5 days - Evaluation of hemostasis after application of product if bleeding at the surgical site occurs - The need for additional procedures (chest drainage, re-operation, respiratory assistance, and blood transfusion) - Time to chest tube removal - Time in surgery (minutes) from incision to closure - Length of stay in hospital (days) - Number of unplanned interventions within 30 days postoperatively - Incidence of adverse events (AEs) including pre-defined postoperative Adverse Events of Special Interest (AESIs) up to 30 + or - 3 days after surgery: 1- Pneumothorax 2- Bronchopleural fistula 3- Emphysema (subcutaneous and mediastinal) 4- Pleural effusions 5- Postoperative respiratory failure 6- Empyema 7- Allergic reactions in reasonable temporal relationship with the product application - Number of patches used (for both investigational and control devices) - Vital signs and laboratory tests ;Timepoint(s) of evaluation of this end point: The secondary endpoints will be assessed during surgery and up to 30 + or - 3 days after surgery. | — |
Countries
Czech Republic, Italy, Spain
Contacts
Public ContactSr Clinical Project Manager
Baxter R&D Europe SPRL
Outcome results
None listed