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

Air Leak From Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04317924
• Other study ID #: H-37652
• Status: Withdrawn
• Phase: N/A
• Start date: October 2020
• Est. completion date: June 2022

Study information

• Verified date: August 2020
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing elective lung resection at BMC

• Intra-operative diagnosis of air leak

Exclusion Criteria:

• Patients undergoing emergency lung resection

Related Conditions & MeSH terms

• Air Leak From Lung

Intervention

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

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Gunze Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Length of hospital stay	The length of hospital stay in days will be abstracted from the electronic medical record of each participant.	2 years
Secondary	Number of participants with additional interventions for air leak	The number of participants requiring additional interventions post lung resection will be abstracted from the electronic medical record of each participant.	2 years