Prolonged Air Leak, Postoperative Air Leak
Conditions
Keywords
lung resection, TachoSil®, Neoveil®, air leak closure, drainage time
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.
Interventions
OTHERTachoSil®
topical absorbable fibrin sealant patch applied directly on the lung area with air fistula.
OTHERNeoveil®
bioabsorbable soft-tissue reinforcement material applied on the normal shape of the lung at the end of the operation.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Blinded participants and unblinded investigators and evaluators
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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) |
Countries
Switzerland
Outcome results
None listed