Not provided
Not provided
Not provided
Not provided
Not provided
Resources not available to conduct the research.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Gunze Limited | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reinforcement of air leak | Experimental | Participants in this arm will receive reinforcement with the NEOVEIL (polyglycolic acid felt) which will be impregnated with human fibrinogen and thrombin. |
|
| No reinforcement of air leak | Active Comparator | Participants in this arm will receive standard of care for air leak post lung resection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyglycolic acid felt | Device | Neoveil is a polyglycolic acid felt that has been shown to decrease the incidence of prolonged air leak after lung resection in Japan. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kei Suzuki, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
|
| Standard of care | Other | Standard of care after air leak post lung resection |
|
The number of participants requiring additional interventions post lung resection will be abstracted from the electronic medical record of each participant.
| 2 years |