SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial Using HEMOPATCH

Quirón Madrid University Hospital170 enrolled

Overview

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."

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

170

Conditions

LUNG DISEASES

Interventions

Hemopatch™ Sealing HemostatDEVICE

Hemopatch™ application over lung resection areas

Standard surgical techniquePROCEDURE

Lung resuturing or restapling

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * Traumatic pulmonary contusion or laceration * 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

Locations (1)

Quirónsalud Madrid University Hospital

Pozuelo de Alarcón, Madrid, Spain

Outcomes

Primary Outcomes

Duration of postoperative air leaks

Duration of postoperative lung air leaks expressed in hours

Time frame: Within first 30 postoperative days

Data from ClinicalTrials.gov

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