Hemopatch Compared to TachoSil in Postoperative Air Leak Duration After Pulmonary Resection (NCT03450265) | Clinical Trial Compass
CompletedNot Applicable
Hemopatch Compared to TachoSil in Postoperative Air Leak Duration After Pulmonary Resection
Italy279 participantsStarted 2018-06-26
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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 ar…