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

Postoperative Air Leak Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04065880
• Other study ID #: 2019-01505; ch19Lardinois
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: May 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 31, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Air Leak
• Prolonged Air Leak

Intervention

Other:
• TachoSil®
topical absorbable fibrin sealant patch applied directly on the lung area with air fistula.
• Neoveil®
bioabsorbable soft-tissue reinforcement material applied on the normal shape of the lung at the end of the operation.

Locations

Country	Name	City	State
Switzerland	Department of Thoracic Surgery, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & 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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of air leak (binary outcome 0/1), i.e. air loss > 30ml	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)
Secondary	Intensity of air leak (continuous outcome, ml)	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)
Secondary	Incidence of prolonged air leak (>10 days) (binary outcome 0/1)	Incidence of prolonged air leak (>10 days) (binary outcome 0/1)	assessed at 10th postoperative day