Pneumostasis With Use of Bio-absorbable Mesh and Fibrin Sealant in Lung Resection

Study Overview
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Brief Summary
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Prolonged air leak, defined as air leak present 5 days after lung resection, is one of the most common complications after lung resection. This leads to patient discomfort (as the chest tube has to stay in place while air leak is present), prolonged stay, and increased cost. NeoVeil is a bioabsorbable glycolic acid which has been used in Japan and other Asian countries for air leak prevention after lung resections. NeoVeil is impregnated with fibrin sealant materials and is placed on the lung surface at the time of operation. It then acts as a scaffold on resected area which is prone to air leak. This randomized clinical trial will be the first in the United States to test its efficacy for air leak prevention.

Official Title
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Use of Polyglycolic Acid Felt for Air-leak Prevention After Lung Resection

Conditions
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Air Leak From Lung

Intervention / Treatment
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* Device: Polyglycolic acid felt
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective lung resection at BMC Intra-operative diagnosis of air leak Exclusion Criteria: Patients undergoing emergency lung resection

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Stratified block randomization will be done using known predictors of prolonged air leak: 1) surgical procedure (wedge vs lobectomy) and 2) presence of pulmonary comorbidities (chronic obstructive pulmonary disease and emphysema).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reinforcement of air leak<br>Participants in this arm will receive reinforcement with the NEOVEIL (polyglycolic acid felt) which will be impregnated with human fibrinogen and thrombin. | Device: Polyglycolic acid felt<br>* Neoveil is a polyglycolic acid felt that has been shown to decrease the incidence of prolonged air leak after lung resection in Japan.<br>* Other names: Neoveil;|
| Active Comparator: No reinforcement of air leak<br>Participants in this arm will receive standard of care for air leak post lung resection. | Other: Standard of care<br>* Standard of care after air leak post lung resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to removal of chest tubes | The time in hours to removal of chest tubes post lung resection will be abstracted from the electronic medical record of each participant. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | The length of hospital stay in days will be abstracted from the electronic medical record of each participant. | 2 years | 
| Number of participants with additional interventions for air leak | The number of participants requiring additional interventions post lung resection will be abstracted from the electronic medical record of each participant. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumostasis, Bio-absorbable mesh, Lung resection, Neoveil