Effectiveness Novel Tissue Sealant, Prevention Prolonged Air Leak (PAL) After Lung Resection

Study Overview
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Brief Summary
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The effectiveness of tissue sealants to prevent Prolonged Air Leak (PAL) after lung resection procedures remains unproved. The investigators hypothesize that one of the main reasons for that is the heterogeneity of previously studied populations. Since currently the risk of postoperative PAL can be scored with a reasonable accuracy, the aim of this research is to investigate the effect of routine application of a novel tissue sealant in patients selected on the basis of a high risk of PAL estimated before surgery.

Official Title
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Prospective, Multicenter, Open-Label, Randomized, Phase III Clinical Trial of Prevention of Prolonged Air Leak After Lung Resection in High-risk Patients, Applying HEMOPATCH®

Conditions
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Prolonged Air Leak, Lung Resection

Intervention / Treatment
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* Device: Hemopatch
* Procedure: standard preventive measures


Participation Criteria
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Eligibility Criteria
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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 assessment are not going to tolerate the procedure Clinical and anesthetic criteria that contraindicate surgery Severe uncontrolled illness Pregnancy Patients that are under Investigational New Drug treatment or have participated in study with a investigational drug (authorized or not) in 30 days before randomization. Lack of Informed Consent or patient refusal Postsurgery mechanical ventilation or repeated surgery in follow-up month.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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. | Device: Hemopatch<br> <br> Procedure: standard preventive measures<br> <br> |
| Other: Control group<br>Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat | Procedure: standard preventive measures<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Prolonged Air Leak (PAL) | 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 | From day of surgery to the fifth postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Air Leaks | Measured as continuous variable (days) and recorded, from day of surgery to the day of withdraw the chest tube. (standardized criteria for pulling out chest drainage/s will be agreed among investigators) | Check everyday from day of surgery up to 38 days post-operative at maximum | 
| Number of Participants With at Least One Chest Tube Reinsertion | Rate of patients needing postoperative reinsertion of chest drainages due to symptomatic pneumothorax. Following daily during hospital stay and pone follow-up until 30th day post-operative. | From day of surgery up to 30 days thereafter | 
| Number of Participants With One or More Readmission | Rate of readmissions due to relapsing pneumothorax (follow-up 30 days) | 30 days post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention PAL Prolonged Air Leak (PAL), Lung Resection, Thoracic Surgery, Post-operative Thoracic Air Leak