PleuraSeal Post Market Study (Europe)

• ClinicalTrials.gov Identifier: NCT00704171
• Recruitment Status: Completed
• First Posted: June 24, 2008
• Results First Posted: March 15, 2010
• Last Update Posted: October 27, 2016
• Sponsor: Integra LifeSciences Corporation
• Collaborator: Medtronic - MITG
• Information provided by (Responsible Party): Integra LifeSciences Corporation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lung Disease; Pulmonary Lobectomy	Procedure: Standard Tissue Closure Techniques; Device: PleuraSeal Lung Sealant System	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 121 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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 Start Date: January 2008
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: PleuraSeal; PleuraSeal Lung Sealant System	Device: PleuraSeal Lung Sealant System; Other Name: PleuraSeal
Active Comparator: Standard of Care; Standard tissue closure techniques (control) - sutures or staples only	Procedure: Standard Tissue Closure Techniques; Standard Tissue Closure Techniques (sutures and staples only); Other Name: Sutures or staples; Device: PleuraSeal Lung Sealant System; Other Name: PleuraSeal

Outcome Measures

Primary Outcome Measures :

1. Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge. [ Time Frame: 30 days ]
2. Percentage of Subjects Remaining Air Leak Free From Skin Closure to Discharge [ Time Frame: 30 days ]
   Sub-analysis by pre-randomization grade of air leak. Grade 1= countable air bubbles, Grade 2= stream of bubbles, Grade 3= coalesced bubbles

Secondary Outcome Measures :

1. Percentage of Subjects for Whom Intra-operative Air Leak Sealing Success is Achieved. [ Time Frame: Intra-operatively, time of study procedure ]
   Success is defined as no presence of air leak intra-operatively.
2. Time From Skin Closure to Last Observable Air Leak. [ Time Frame: 30 days ]
3. Duration of Chest Drainage [ Time Frame: 30 days ]
4. Duration of Hospitalization [ Time Frame: 30 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Massachusetts

Covidien

Bedford, Massachusetts, United States, 01730

Austria

Universitaetsklinik - Landeskrankenhaus Innsbruck

Innsbruck, Austria

Otto Wagner Spital

Vienna, Austria

Belgium

Hopital Erasme

Brussels, Belgium

University Hospitals Leuven

Leuven, Belgium

Netherlands

VU-Medisch Centrum

Amsterdam, Netherlands

Medical Centre Rotterdam Zuid

Rotterdam, Netherlands

Switzerland

University Hospital - Zurich

Zurich, Switzerland

United Kingdom

Papworth Hospital

Cambridge, United Kingdom

Sponsors and Collaborators

Integra LifeSciences Corporation

Medtronic - MITG

Investigators

• Study Director: Jennifer Doyle; Senior Director, Clinical Affairs at Covidien (formerly Confluent)
• Principal Investigator: Paul De Leyn, MD, PhD; Universitaire Ziekenhuizen Leuven

More Information

• Responsible Party: Integra LifeSciences Corporation
• ClinicalTrials.gov Identifier: NCT00704171
• Other Study ID Numbers: LUN-06-002
• First Posted: June 24, 2008
• Results First Posted: March 15, 2010
• Last Update Posted: October 27, 2016
• Last Verified: September 2016

Keywords provided by Integra LifeSciences Corporation:

Elective pulmonary resection via open thoracotomy.

Additional relevant MeSH terms:

Lung Diseases; Respiratory Tract Diseases