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

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

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."

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