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

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Completed
• CT.gov ID: NCT04065880
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Actual Duration (Months): 16
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prolonged Air Leak; Postoperative Air Leak	Other: TachoSil®; Other: Neoveil®	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: Blinded participants and unblinded investigators and evaluators
• Primary Purpose: Other
• Official Title: Neoveil® Versus TachoSil® for the Treatment of Pulmonary Air Leaks Following Lung Operation
• Actual Study Start Date: Apr 1, 2020
• Actual Primary Completion Date: Jul 1, 2021
• Actual Study Completion Date: Jul 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. time required till air leak closure has occurred (hours) [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 Outcome Measures

1. 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)]

   Incidence of air leak (binary outcome 0/1), i.e. air loss > 30ml

2. 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)]

   Intensity of air leak (continuous outcome, ml)

3. Incidence of prolonged air leak (>10 days) (binary outcome 0/1) [assessed at 10th postoperative day]

   Incidence of prolonged air leak (>10 days) (binary outcome 0/1)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Thoracic Surgery, University Hospital Basel	Basel		Switzerland	4031

Sponsors and Collaborators

• University Hospital, Basel, Switzerland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT04065880
• Other Study ID Numbers: 2019-01505; ch19Lardinois
• First Posted: Aug 22, 2019
• Last Update Posted: Oct 7, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Basel, Switzerland: lung resection; TachoSil®; Neoveil®; air leak closure; drainage time

Study Results

No Results Posted as of Oct 7, 2021