A Prospective Multi-Center Randomized Post Market Study to Evaluate the PleuraSeal Sealant System as an Adjunct to Standard Closure Techniques for Control of Visceral Pleural Air Leaks Following Elective Pulmonary Resection Via Open Thoracotomy.
- Conditions
- and segmentectomy (limited resection in case of reduced functional operability) in one or more lobes via an open thoracotomy.The study objective is to further characterize the PleuraSeal Sealant System as compared to standard of care (sutures and staples only) in subjects undergoing an elective pulmonary lobectomy10035597
- Registration Number
- NL-OMON31438
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
* * 18 years old
* Scheduled for an elective pulmonary lobectomy, and segmentectomy (limited resection in case of reduced functional operability) in one or more lobes via an open thoracotomy
* Subject has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Ethics Committee (EC) of the respective clinical site
* At least one intraoperative air leak identified during lung immersion leak test after the initial closure is completed
* Hemostasis must be confirmed prior to randomization
* Documented history of bleeding disorders and/or severely altered renal or hepatic function
* Compromised immune system (e.g., HIV/acquired immunodeficiency syndrome, immunosuppressive therapy)
* Prior ipsilateral thoracotomy
* Subject with Tuberculosis
* Extensive adhesions from previous thoracic trauma or surgery
* Undergoing lung volume reduction surgery, wedge resection, pneumonectomy, sleeve resection or bronchoplasty, blebectomy, bullectomy, pleurodesis, lung transplant , or living lobe transplant donor
* Subject has active systemic or pulmonary infection
* Treated with chronic steroid therapy unless discontinued more than 6 weeks prior to surgery (standard acute perioperative steroids are permitted).
* Pregnant (documented by pregnancy test), breast-feeding, or that wish to become pregnant during the course of the study or not willing to use birth control
* Documented history of uncontrolled diabetes
* Subject has an estimated life expectancy of less than 6 months
* Currently enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this study
* Congestive heart failure, COR pulmonale or other condition that, in the opinion of the investigator, may jeopardize the subject*s well-being and/or negatively impact the interpretation of data collected during the clinical study
* Unable to comply with the study requirements or follow-up schedule
* Procedure performed via VATS only
* Air leaks originating from bronchioles > 1 mm in diameter that can not be primarily closed or a residual tidal volume loss of * 30%
* Extensive intrathoracic adhesions present
* Exploratory thoracotomy performed only
* Pneumonectomy, wedge resection, sleeve resection, bronchoplasty, blebectomy or bullectomy performed
* Incidental finding of any other pre-operative exclusion criteria
* Use of buttressing materials or other non-autologous staple/suture line reinforcement or other surgical sealants when used for pulmonary sealing (i.e., use of hemostatic agents for hemostasis is permitted)
* Investigator determines that participation in the study may jeopardize the safety or welfare of the subject.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Proportion of subjects remaining air leak free from the time of skin closure to<br /><br>hospital discharge. (device performance) </p><br>
- Secondary Outcome Measures
Name Time Method <p>* Proportion of subjects for whom intra-operative air leak sealing success is<br /><br>achieved. (device performance)<br /><br>* Time from skin closure to last observable air leak (device performance)<br /><br>* Duration of chest drainage (device performance)<br /><br>* Duration of hospitalization (device performance)<br /><br>* Incidence of complications ( only Cancer progression, Illeus/ Intestinal<br /><br>Obstruction, Colitis/ gastroenteritis, urinary tract infection, congestive<br /><br>heart failure, pleural empyema, wound infection and surgical site infections)<br /><br>(safety)<br /><br>* Changes form baseline in laboratory values and in laboratory value normal/<br /><br>abnormal status. (safety)</p><br>