SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial Using HEMOPATCH
NCT ID: NCT02668978
Last Updated: 2019-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
170 participants
INTERVENTIONAL
2016-03-31
2019-08-31
Brief Summary
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Hypothesis: "The routine application of HEMOPATCH Sealing Hemostat on the visceral pleura in lung resection areas, during lung resection procedures, is more EFFICIENT to reduce the incidence and duration of prolonged air leaks as compared to standard surgical measures."
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Hemopatch™
Hemopatch™ sealing hemostat
Hemopatch™ Sealing Hemostat
Hemopatch™ application over lung resection areas
Control
Standard surgical technique
Standard surgical technique
Lung resuturing or restapling
Interventions
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Hemopatch™ Sealing Hemostat
Hemopatch™ application over lung resection areas
Standard surgical technique
Lung resuturing or restapling
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing lung resection surgery for either malignant or benign conditions including:
* Lobar and sublobar resections
* Open, video-assisted thoracoscopic or robotic surgeries
* Diagnostic or therapeutic procedures
Exclusion Criteria
* Lung reduction surgery
* Planned removal of more than 10 lung lesions
* Pneumonectomy
* Known hypersensitivity to bovine protein
* Known hypersensitivity to Brilliant Blue FCF (E133)
* Presence of active infection
18 Years
ALL
No
Sponsors
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Baxter BioScience
INDUSTRY
Quirón Madrid University Hospital
OTHER
Responsible Party
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Javier MORADIELLOS
Associate Chief of Thoracic Surgery
Locations
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Quirónsalud Madrid University Hospital
Pozuelo de Alarcón, Madrid, Spain
Countries
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Other Identifiers
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SEALLS
Identifier Type: -
Identifier Source: org_study_id
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