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

August 31, 2019 updated by: Javier MORADIELLOS, Quirón Madrid University Hospital

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."

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 280222
        • Quirónsalud Madrid University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of postoperative air leaks
Time Frame: Within first 30 postoperative days
Duration of postoperative lung air leaks expressed in hours
Within first 30 postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quirón Madrid University Hospital

Collaborators

Baxter BioScience

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

August 31, 2019

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

August 31, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEALLS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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