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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
121
Standard Tissue Closure Techniques (sutures and staples only)
Covidien
Bedford, Massachusetts, United States
Universitaetsklinik - Landeskrankenhaus Innsbruck
Innsbruck, Austria
Otto Wagner Spital
Vienna, Austria
Hopital Erasme
Brussels, Belgium
Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge.
Time frame: 30 days
Percentage of Subjects Remaining Air Leak Free From Skin Closure to Discharge
Sub-analysis by pre-randomization grade of air leak. Grade 1= countable air bubbles, Grade 2= stream of bubbles, Grade 3= coalesced bubbles
Time frame: 30 days
Percentage of Subjects for Whom Intra-operative Air Leak Sealing Success is Achieved.
Success is defined as no presence of air leak intra-operatively.
Time frame: Intra-operatively, time of study procedure
Time From Skin Closure to Last Observable Air Leak.
Time frame: 30 days
Duration of Chest Drainage
Time frame: 30 days
Duration of Hospitalization
Time frame: 30 days
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University Hospitals Leuven
Leuven, Belgium
VU-Medisch Centrum
Amsterdam, Netherlands
Medical Centre Rotterdam Zuid
Rotterdam, Netherlands
University Hospital - Zurich
Zurich, Switzerland
Papworth Hospital
Cambridge, United Kingdom