NCT04065880

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

May 15, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

August 20, 2019

Last Update Submit

May 10, 2023

Conditions

Prolonged Air LeakPostoperative Air Leak

Keywords

lung resectionTachoSil®Neoveil®air leak closuredrainage time

Outcome Measures

Primary Outcomes (1)

  • time required till air leak closure has occurred (hours)

    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 Outcomes (3)

  • 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)

    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)

    assessed at 10th postoperative day

Study Arms (2)

TachoSil®

ACTIVE COMPARATOR

TachoSil® is a collagen sponge coated with the human coagulation factors fibrinogen and thrombin.

Other: TachoSil®

Neoveil®

ACTIVE COMPARATOR

Neoveil® sheet made of polyglycolic acid (PGA). It is a biodegradable, thermoplastic and non-antigenic polymer.

Other: Neoveil®

Interventions

TachoSil®OTHER

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

TachoSil®
Neoveil®OTHER

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

Neoveil®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Thoracic Surgery, University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

  • Bachmann H, Dackam SVC, Hojski A, Jankovic J, Vogt DR, Wiese MN, Lardinois D. Neoveil versus TachoSil in the treatment of pulmonary air leak following open lung surgery: a prospective randomized trial. Eur J Cardiothorac Surg. 2022 Dec 2;63(1):ezad003. doi: 10.1093/ejcts/ezad003.

    PMID: 36651370RESULT

MeSH Terms

Interventions

TachoSil

Study Officials

  • Didier Lardinois, Prof. MD

    Department of Thoracic Surgery, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Blinded participants and unblinded investigators and evaluators
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2019

First Posted

August 22, 2019

Study Start

April 1, 2020

Primary Completion

July 1, 2021

Study Completion

July 31, 2021

Last Updated

May 15, 2023

Record last verified: 2023-05

Locations

CH(1)