Neoveil® Versus TachoSil® for the Treatment of Pulmonary Air Leaks Following Lung Operation

May 10, 2023 updated by: University Hospital, Basel, Switzerland
Postoperative prolonged air leak (PAL), referring to the passage of air from the lung parenchyma into the pleural space, is one of the most frequent postoperative complications after lung resection. To control air leak, there are two different products certified since years: TachoSil® and Neoveil®. This study is to investigate the difference of TachoSil® and Neoveil® in patients with PAL.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

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

  • Switzerland
      • Basel, Switzerland, 4031
        • Department of Thoracic Surgery, University Hospital Basel

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with a pulmonary air leak following open lung surgery, regardless of whether an anatomical or atypical resection was performed
  • Patients who are able to decide for themselves whether to participate in the study or not ( for example due to language problems, mental disorders, dementia of the participant)
  • Patients who are not family member or employee of the investigator

Exclusion Criteria:

  • Inability to follow the procedures of the study, for example, due to language problems, mental disorders, dementia of the participant
  • Enrolment of the investigator, his/her family members, employees and other dependent persons

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TachoSil®
TachoSil® is a collagen sponge coated with the human coagulation factors fibrinogen and thrombin.
Other: TachoSil®
topical absorbable fibrin sealant patch applied directly on the lung area with air fistula.
Active Comparator: Neoveil®
Neoveil® sheet made of polyglycolic acid (PGA). It is a biodegradable, thermoplastic and non-antigenic polymer.
Other: Neoveil®
bioabsorbable soft-tissue reinforcement material applied on the normal shape of the lung at the end of the operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time required till air leak closure has occurred (hours)
Time Frame: end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day)
time interval between end of the operation (closure of the skin) and air leak closure (less than 30ml on the digitalized drainage system).
end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of air leak (binary outcome 0/1), i.e. air loss > 30ml
Time Frame: end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day)
Incidence of air leak (binary outcome 0/1), i.e. air loss > 30ml
end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day)
Intensity of air leak (continuous outcome, ml)
Time Frame: end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day)
Intensity of air leak (continuous outcome, ml)
end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day)
Incidence of prolonged air leak (>10 days) (binary outcome 0/1)
Time Frame: assessed at 10th postoperative day
Incidence of prolonged air leak (>10 days) (binary outcome 0/1)
assessed at 10th postoperative day

Collaborators and Investigators

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

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Didier Lardinois, Prof. MD, Department of Thoracic Surgery, University Hospital Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

April 1, 2020

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

August 20, 2019

First Submitted That Met QC Criteria

August 20, 2019

First Posted (Actual)

August 22, 2019

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019-01505; ch19Lardinois

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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