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

Primary Purpose

LUNG DISEASES

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Hemopatch™ Sealing Hemostat
Standard surgical technique
Sponsored by
Quirón Madrid University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for LUNG DISEASES focused on measuring lung surgery, air leak, prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Quirónsalud Madrid University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hemopatch™

Control

Arm Description

Hemopatch™ sealing hemostat

Standard surgical technique

Outcomes

Primary Outcome Measures

Duration of postoperative air leaks
Duration of postoperative lung air leaks expressed in hours

Secondary Outcome Measures

Full Information

First Posted
January 27, 2016
Last Updated
August 31, 2019
Sponsor
Quirón Madrid University Hospital
Collaborators
Baxter BioScience
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1. Study Identification

Unique Protocol Identification Number
NCT02668978
Brief Title
SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial Using HEMOPATCH
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Quirón Madrid University Hospital
Collaborators
Baxter BioScience

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
LUNG DISEASES
Keywords
lung surgery, air leak, prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hemopatch™
Arm Type
Experimental
Arm Description
Hemopatch™ sealing hemostat
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard surgical technique
Intervention Type
Device
Intervention Name(s)
Hemopatch™ Sealing Hemostat
Intervention Description
Hemopatch™ application over lung resection areas
Intervention Type
Procedure
Intervention Name(s)
Standard surgical technique
Intervention Description
Lung resuturing or restapling
Primary Outcome Measure Information:
Title
Duration of postoperative air leaks
Description
Duration of postoperative lung air leaks expressed in hours
Time Frame
Within first 30 postoperative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Quirónsalud Madrid University Hospital
City
Pozuelo de Alarcón
State/Province
Madrid
ZIP/Postal Code
280222
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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