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

University Hospital Basel logo

University Hospital Basel

Status

Completed

Conditions

Prolonged Air Leak
Postoperative Air Leak

Treatments

Other: Neoveil®
Other: TachoSil®

Study type

Interventional

Funder types

Other

Identifiers

NCT04065880
2019-01505 ch19Lardinois;

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

46 participants in 2 patient groups

TachoSil®
Active Comparator group
Description:
TachoSil® is a collagen sponge coated with the human coagulation factors fibrinogen and thrombin.
Treatment:
Other: TachoSil®
Neoveil®
Active Comparator group
Description:
Neoveil® sheet made of polyglycolic acid (PGA). It is a biodegradable, thermoplastic and non-antigenic polymer.
Treatment:
Other: Neoveil®

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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