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

Quirón Madrid University Hospital

Status and phase: Completed; Phase 4

Conditions: LUNG DISEASES

Treatments: Device: Hemopatch™ Sealing Hemostat; Procedure: Standard surgical technique

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02668978

SEALLS

Details and patient eligibility

About

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."

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

Hemopatch™

Experimental group

Description:

Hemopatch™ sealing hemostat

Treatment:

Device: Hemopatch™ Sealing Hemostat

Control

Active Comparator group

Description:

Standard surgical technique

Treatment:

Procedure: Standard surgical technique