Pneumostasis With Use of Bio-absorbable Mesh and Fibrin Sealant in Lung Resection
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|ClinicalTrials.gov Identifier: NCT04317924|
Recruitment Status : Withdrawn (Resources not available to conduct the research.)
First Posted : March 23, 2020
Last Update Posted : August 26, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Air Leak From Lung||Device: Polyglycolic acid felt Other: Standard of care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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)|
|Official Title:||Use of Polyglycolic Acid Felt for Air-leak Prevention After Lung Resection|
|Estimated Study Start Date :||October 2020|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
Experimental: Reinforcement of air leak
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
Neoveil is a polyglycolic acid felt that has been shown to decrease the incidence of prolonged air leak after lung resection in Japan.
Other Name: Neoveil
Active Comparator: No reinforcement of air leak
Participants in this arm will receive standard of care for air leak post lung resection.
Other: Standard of care
Standard of care after air leak post lung resection
- Time to removal of chest tubes [ Time Frame: 2 years ]The time in hours to removal of chest tubes post lung resection will be abstracted from the electronic medical record of each participant.
- Length of hospital stay [ Time Frame: 2 years ]The length of hospital stay in days will be abstracted from the electronic medical record of each participant.
- Number of participants with additional interventions for air leak [ Time Frame: 2 years ]The number of participants requiring additional interventions post lung resection will be abstracted from the electronic medical record of each participant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04317924
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Kei Suzuki, MD||Boston Medical Center|