PleuraSeal Post Market Study (Europe)

Lung Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00704171
• Other study ID #: LUN-06-002
• Status: Completed
• Phase: Phase 4
• First received: June 23, 2008
• Last updated: September 4, 2014
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: September 2014
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Disease
• Lung Diseases
• Pulmonary Lobectomy

Intervention

Procedure:
• Standard Tissue Closure Techniques
Standard Tissue Closure Techniques (sutures and staples only)

Device:
• PleuraSeal Lung Sealant System

Locations

Country	Name	City	State
Austria	Universitaetsklinik - Landeskrankenhaus Innsbruck	Innsbruck
Austria	Otto Wagner Spital	Vienna
Belgium	Hopital Erasme	Brussels
Belgium	University Hospitals Leuven	Leuven
Netherlands	VU-Medisch Centrum	Amsterdam
Netherlands	Medical Centre Rotterdam Zuid	Rotterdam
Switzerland	University Hospital - Zurich	Zurich
United Kingdom	Papworth Hospital	Cambridge
United States	Covidien	Bedford	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation	Medtronic - MITG

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge.		30 days	No
Primary	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	30 days	No
Secondary	Percentage of Subjects for Whom Intra-operative Air Leak Sealing Success is Achieved.	Success is defined as no presence of air leak intra-operatively.	Intra-operatively, time of study procedure	No
Secondary	Time From Skin Closure to Last Observable Air Leak.		30 days	No
Secondary	Duration of Chest Drainage		30 days	No
Secondary	Duration of Hospitalization		30 days	No