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

Phase 4

Completed

• Conditions: LUNG DISEASES
• Interventions: Device: Hemopatch™ Sealing Hemostat; Procedure: Standard surgical technique

• Registration Number: NCT02668978
• Lead Sponsor: Quirón Madrid University Hospital

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."

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-27
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-01-29
• Study Start: 2016-03
• Status Verified: 2019-08
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Last Update Submitted: 2019-08-31
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemopatch™	Hemopatch™ Sealing Hemostat	Hemopatch™ sealing hemostat
Control	Standard surgical technique	Standard surgical technique

Primary Outcome Measures

Name	Time	Method
Duration of postoperative air leaks	Within first 30 postoperative days	Duration of postoperative lung air leaks expressed in hours

Trial Locations

Locations (1)

Quirónsalud Madrid University Hospital; 🇪🇸 Pozuelo de Alarcón, Madrid, Spain