A Phase II Prospective, Single Blinded, Randomized Trial of Hemopatch Compared to Standard Techniques to Achieve Air Leak Control After Complex Thoracic Surgical Procedures

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Thoracic Surgery Lung, Post-operative Thoracic Air Leak

Intervention / Treatment
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* Device: standard techniques used to achieve air leak control
* Device: Hemopatch


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard treatment<br>standard techniques to achieve air leak control after complex thoracic surgical procedures | Device: standard techniques used to achieve air leak control<br> <br> |
| Experimental: standard treatment plus hemopatch<br>the addition of hemopatch to standard techniques to achieve air leak control after complex thoracic surgical procedures | Device: standard techniques used to achieve air leak control<br> <br> Device: Hemopatch<br> <br> * Other names: sealing hemostat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of days from time of extubation to time of drainage tube removal |  | up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of days to end of air leak | air leak measure are recorded every 6 hours | up to 7 days | 
| worst grade toxicity per patient | according to Common Terminology Criteria for Adverse Events version 4.0 | up to 6 weeks | 
| change in quality of life |  | baseline, one week, one month | 
| number of days from surgical intervention to patient discharge |  | up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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segmentectomy, lobectomy, chest tube, pulmonary resection