A Study to Evaluate the Efficacy and Safety of Hemopatch Compared to TachoSil in Preventing or Reducing Postoperative Air Leaks After Pulmonary Resection.
- Conditions
- Postoperative air leakage.MedDRA version: 20.0Level: PTClassification code 10067826Term: Pulmonary air leakageSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2017-003931-12-CZ
- Lead Sponsor
- Baxter Healthcare Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 166
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 primary endpoint for assessing the efficacy of Hemopatch compared to TachoSil is the duration of patients’ postoperative air leakage, measured in days.;Timepoint(s) of evaluation of this end point: 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 Outcome Measures
Name Time Method