Prospective Randomized Clinical Trial to Prevent Air Leaks After Lung Resection With Hemopatch™ Sealing Hemostat: SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial

Quirón Madrid University Hospital1 site in 1 country170 target enrollmentMarch 2016

ConditionsLUNG DISEASES

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: LUNG DISEASES
Sponsor: Quirón Madrid University Hospital
Enrollment: 170
Locations: 1
Primary Endpoint: Duration of postoperative air leaks
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective is to assess the efficacy and safety of HEMOPATCH™ Sealing Hemostat in reducing the incidence and duration of air leaks after lung resection compared to standard techniques.

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."

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

August 31, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Quirón Madrid University Hospital

Responsible Party

Principal Investigator

Javier MORADIELLOS

Associate Chief of Thoracic Surgery

Quirón Madrid University Hospital

Eligibility Criteria

Inclusion Criteria

•Patients over the age of 18 years who are able to give their informed consent
•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