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

• Sponsor: Quirón Madrid University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02668978
• Collaborator: Baxter BioScience (Industry)
• Enrollment: 170
• Location: 1
• Arms: 2
• Actual Duration (Months): 42
• Patients Per Site Per Month: 4

Study Details

Study Description

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."

Condition or Disease	Intervention/Treatment	Phase
LUNG DISEASES	Device: Hemopatch™ Sealing Hemostat; Procedure: Standard surgical technique	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 170 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Aug 31, 2019
• Actual Study Completion Date: Aug 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hemopatch™ Hemopatch™ sealing hemostat	Device: Hemopatch™ Sealing Hemostat; Hemopatch™ application over lung resection areas
Active Comparator: Control Standard surgical technique	Procedure: Standard surgical technique; Lung resuturing or restapling

Outcome Measures

Primary Outcome Measures

1. Duration of postoperative air leaks [Within first 30 postoperative days]

   Duration of postoperative lung air leaks expressed in hours

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quirónsalud Madrid University Hospital	Pozuelo de Alarcón	Madrid	Spain	280222

Sponsors and Collaborators

• Quirón Madrid University Hospital
• Baxter BioScience

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Javier MORADIELLOS, Associate Chief of Thoracic Surgery, Quirón Madrid University Hospital
• ClinicalTrials.gov Identifier: NCT02668978
• Other Study ID Numbers: SEALLS
• First Posted: Jan 29, 2016
• Last Update Posted: Sep 4, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Javier MORADIELLOS, Associate Chief of Thoracic Surgery, Quirón Madrid University Hospital: lung surgery; air leak; prevention
• Additional relevant MeSH terms: Lung Diseases

Study Results

No Results Posted as of Sep 4, 2019