Post-operative Thoracic Air Leak Clinical Trial
— HemopatchOfficial title:
A Phase II Prospective, Single Blinded, Randomized Trial of Hemopatch Compared to Standard Techniques to Achieve Air Leak Control After Complex Thoracic Surgical Procedures on High Risk Population for Prolonged Air Leak (> 5 Days - PAL).
| Verified date | March 2023 |
| Source | National Cancer Institute, Naples |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to explore whether the addition of Hemopatch to standard care can reduce prolonged air leaks and shorten the use of air drainage tube after surgery in thoracic lung surgery patients at high risk for prolonged air leaks.
| Status | Active, not recruiting |
| Enrollment | 120 |
| Est. completion date | December 2024 |
| Est. primary completion date | December 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Age =18 years - High risk of prolonged air leak due to at least one of the following reasons: - Preoperative FEV1<80% - DLco < 80% - LVRS (lung volume reduction surgery o pneumoplastica riduttiva) - Anticipation of intraoperative adhesions (ie, redo surgery) - Previous induction chemotherapy for locally advanced NSCLC - Chronic steroid use - Pleural mesothelioma - Candidate to one of the following major thoracic surgical intervention: - Decortication - Reintervention on the same side of the previous intervention - Segmentectomy - Lobectomy with incomplete fissures on CT scan - Written informed consent. Exclusion Criteria: - Pregnancy or breast-feeding - Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient's understanding of the Informed Consent Form or their ability to comply with study requirements - Any unstable systemic disease (including active infections, any significant hepatic, renal or cardiovascular disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates or prevents or the execution of surgery - Known hypersensitivity to bovine proteins or brilliant blue (FD&C Blue No.1) |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS | Napoli |
| Lead Sponsor | Collaborator |
|---|---|
| National Cancer Institute, Naples | Baxter Healthcare Corporation, European Institute of Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Istituto Clinico Humanitas, Regina Elena Cancer Institute |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | number of days from time of extubation to time of drainage tube removal | up to 7 days | ||
| Secondary | number of days to end of air leak | air leak measure are recorded every 6 hours | up to 7 days | |
| Secondary | worst grade toxicity per patient | according to Common Terminology Criteria for Adverse Events version 4.0 | up to 6 weeks | |
| Secondary | change in quality of life | baseline, one week, one month | ||
| Secondary | number of days from surgical intervention to patient discharge | up to 2 weeks |