Clinical trial NCT00704171: PleuraSeal Post Market Study (Europe)
Official title: Prospective Multi-Center Randomized Post Market Study to Evaluate the PleuraSeal Sealant System as Adjunct to Standard Closure Techniques for Control of Visceral Pleural Air Leaks Following Elective Pulmonary Resection Via Open Thoracotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lung Disease
Pulmonary Lobectomy
Keywords: Elective pulmonary resection via open thoracotomy.
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Medtronic - MITG
First posted: 2008-06-24
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To further characterize the PleuraSeal Sealant System as compared to standard of care (sutures and staples only) in subjects undergoing an elective pulmonary lobectomy and segmentectomy via open thoractomy.


Eligibility criteria: Pre-Operative Inclusion Criteria:

* Subjects 18 years of age or older
* 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 or authorized representative has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Ethics Committee of teh respective clinical site

Pre-Operative Exclusion Criteria:

* 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). For purposes of this protocol, chronic steroid therapy is defined as greater than 4 weeks
* 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 (e.g. IUD; oral, transdermal or parenteral contraceptives; abstinence)
* 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

Intra-Operative Inclusion Criteria:

* At least one intra-operative air leak identified during lung submersion leak test after the initial closure is completed
* Hemostasis must be confirmed prior to randomization

Intra-Operative Exclusion Criteria:

* Procedure performed via VATS only
* Air leaks originating from bronchioles \>1 mm in diameter that cannot be primarily closed or a residual tidal volume loss of \>=30%
* Extensive intra-thoracic adhesions present
* Exploratory thoracotomy performed only
* Pneumonectomy, wedge resection, sleeve resection, pleurodesis, 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); however, the sealant should not be applied over intact hemostatic material and all hemostat should be removed prior to sealant application
* Investigator determines that participation in the study may jeopardize the safety or welfare of the subject

Primary outcomes:
measure: Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge.
timeFrame: 30 days
measure: Percentage of Subjects Remaining Air Leak Free From Skin Closure to Discharge
timeFrame: 30 days
Secondary outcomes:
measure: Percentage of Subjects for Whom Intra-operative Air Leak Sealing Success is Achieved.
timeFrame: Intra-operatively, time of study procedure
measure: Time From Skin Closure to Last Observable Air Leak.
timeFrame: 30 days
measure: Duration of Chest Drainage
timeFrame: 30 days
measure: Duration of Hospitalization
timeFrame: 30 days
Other outcomes:
Locations:
city: Bedford
country: United States
facility: Covidien
state: Massachusetts
city: Innsbruck
country: Austria
facility: Universitaetsklinik - Landeskrankenhaus Innsbruck
city: Vienna
country: Austria
facility: Otto Wagner Spital
city: Brussels
country: Belgium
facility: Hopital Erasme
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Amsterdam
country: Netherlands
facility: VU-Medisch Centrum
city: Rotterdam
country: Netherlands
facility: Medical Centre Rotterdam Zuid
city: Zurich
country: Switzerland
facility: University Hospital - Zurich
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
Study officials:
affiliation: Senior Director, Clinical Affairs at Covidien (formerly Confluent)
name: Jennifer Doyle
role: STUDY_DIRECTOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Paul De Leyn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: