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OpenTrials
Completed

NCT Number: NCT04065880

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

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.

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Key information

Conditions

Prolonged Air Leak Postoperative Air Leak

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Thoracic Surgery, University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TachoSil®

Other

topical absorbable fibrin sealant patch applied directly on the lung area with air fistula.

Neoveil®

Other

bioabsorbable soft-tissue reinforcement material applied on the normal shape of the lung at the end of the operation.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 22, 2019
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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