Primary or secondry lung cancer, or other parenchymal disease for which pulmonary resection surgery is indicated 3. Patients eligible for anatomical or atypical pulmonary resection lobe resection bilobectomy typical segment resection wedge resection MedDRA version: 9.1 Level: LLT Classification code 10024741 Term: Lung lobectomy
Conditions
Interventions
Product Name: Kedrion Fibrin Sealant
Pharmaceutical Form: Sealant
INN or Proposed INN: trombina
fibrinogeno
aprotinina
cloruro di calcio biidrato
Concentration unit: ml millilitre(s)
Concentration type: equal
Sponsors
KEDRION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 to 75 years old 2. Primary or secondry lung cancer, or other parenchymal disease for which pulmonary resection surgery is indicated 3. Patients eligible for anatomical or atypical pulmonary resection lobe resection bilobectomy typical segment resection wedge resection 4. Open surgical access (standard thoracotomies, mini-thoracotomies, muscle preserving thoracotomies) 5. Life expectancy > six months 6. The subjects or their authorized legal representatives must have received adequate information regarding the nature of the trial, agree on study purposes, and have signed an informed consent form approved by the Ethical Committee. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: hypersensitivity to active substances or to any of the excipients and others similar products Parenchymal reseections with the use of thoracoscopy 2. Previous ipsilateral thoracotomies 3. Patients with lung cancer treated with neo-adjuvants (Chemotherapy or Radiotherapy) 4. Patients treated with Pneumonectomy 5. Karnofsky Performance Status (KPS) ≤50 6. Immunocompromised patients 7. Lab test results: Bilirubin >1.5 g/dl Alkaline phosphatase >120 iu/l Blood creatinine > 1.5 mg/dl WBC >10,000/mm3 8. Positive pregnancy test 9. Presence of any conditions which, in the investigator?s judgment, may interfere with study objective evaluation or with the patient?s participation in the study. 10. The patient refused to sign the written informed consent required for participation, or participated in another clinical study during the month prior to study start date (the subject received other study drugs during the last 30 days).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to verify the efficacy and safety of IMP used for Aerostasis control in pulmonary resection surgery.;Secondary Objective: reduction of ospedalization;Primary end point(s): reduction of time the drainage is retained in each patient. | — |
Countries
Italy
Outcome results
None listed