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

Boston Medical Center (BMC)

Status: Withdrawn

Conditions: Air Leak From Lung

Treatments: Other: Standard of care; Device: Polyglycolic acid felt

Study type: Interventional

Funder types: Other

Identifiers

NCT04317924

H-37652

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing elective lung resection at BMC
• Intra-operative diagnosis of air leak

Exclusion criteria

• Patients undergoing emergency lung resection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Reinforcement of air leak

Experimental group

Description:

Participants in this arm will receive reinforcement with the NEOVEIL (polyglycolic acid felt) which will be impregnated with human fibrinogen and thrombin.

Treatment:

Device: Polyglycolic acid felt

No reinforcement of air leak

Active Comparator group

Description:

Participants in this arm will receive standard of care for air leak post lung resection.

Treatment:

Other: Standard of care