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

Baxter

Status: Completed

Conditions: Air Leak From Lung

Treatments: Device: Tachosil; Device: Hemopatch

Study type: Interventional

Funder types: Industry

Identifiers

NCT03450265

BXU513667

2017-003931-12 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 279 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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279 participants in 2 patient groups

Hemopatch

Experimental group

Description:

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.

Treatment:

Device: Hemopatch

TachoSil

Active Comparator group

Description:

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.

Treatment:

Device: Tachosil