Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02491671 | Effectiveness Novel Tissue Sealant, Prevention Prolonged Air Leak (PAL) After Lung Resection | PHASE3 | COMPLETED | 260 | — | — | Nov 24, 2015 | Jun 30, 2019 | Aug 9, 2021 | 6 | Spain |
Prevalence of Prolonged Air Leak (PAL) measured as binary variable (YES/NO) and recorded, from day of surgery to the fifth postoperative day, in the study questionnaire. The occurrence of the outcome will be recorded if air leak exists 5 days or more after surgery
| Arm | Type | Description |
|---|---|---|
| Experimental group | EXPERIMENTAL | Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis. |
| Control group | OTHER | Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat |
| Name | Type | Description |
|---|---|---|
| Hemopatch | DEVICE | - |
| standard preventive measures | PROCEDURE | - |
Inclusion Criteria: * Scheduled anatomical lung resection indicated for any non-infectious disease (excluding Pneumonectomy) * Patients classified in class D according estimated risk of PAL * Age between 18 and 80 years Exclusion Criteria: * Those patients that according to Investigator assessmen...