NCT04317924

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Air Leak From Lung

Interventions

Type	Name	Description
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	Standard of care	Standard of care after air leak post lung resection

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2020-03-23
• Last updated: 2020-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study