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

Not Applicable

Withdrawn

• Conditions: Air Leak From Lung
• Interventions: Device: Polyglycolic acid felt; Other: Standard of care

• Registration Number: NCT04317924
• Lead Sponsor: Boston Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-23
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-24
• Last Update Posted: 2020-08-26
• Study Start: 2020-10
• Primary Completion: 2022-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• Patients undergoing emergency lung resection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reinforcement of air leak	Polyglycolic acid felt	Participants in this arm will receive reinforcement with the NEOVEIL (polyglycolic acid felt) which will be impregnated with human fibrinogen and thrombin.
No reinforcement of air leak	Standard of care	Participants in this arm will receive standard of care for air leak post lung resection.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Length of hospital stay	2 years	The length of hospital stay in days will be abstracted from the electronic medical record of each participant.

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States