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Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04317924

Enrollment

Registered

2020-03-23

Start date

2020-10-31

Completion date

2022-06-30

Last updated

2020-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Air Leak From Lung

Keywords

Pneumostasis, Bio-absorbable mesh, Lung resection, Neoveil

Brief 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.

Interventions

DEVICEPolyglycolic 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.

OTHERStandard of care

Standard of care after air leak post lung resection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

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).

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Patients undergoing emergency lung resection

Design outcomes

Primary

Measure	Time frame	Description
Time to removal of chest tubes	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.

Secondary

Measure	Time frame	Description
Length of hospital stay	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	2 years	The number of participants requiring additional interventions post lung resection will be abstracted from the electronic medical record of each participant.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026