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

NCT04317924 | Withdrawn FDA Device

• 1 other identifier: H-37652
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Air Leak From Lung

Keywords

Pneumostasis; Bio-absorbable mesh; Lung resection; Neoveil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Length of hospital stay

  2 years

• Number of participants with additional interventions for air leak

  2 years

Study Arms (2)

Reinforcement of air leak

EXPERIMENTAL

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

Device: Polyglycolic acid felt

No reinforcement of air leak

ACTIVE COMPARATOR

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

Other: Standard of care

Interventions

Polyglycolic acid felt DEVICE

Neoveil is a polyglycolic acid felt that has been shown to decrease the incidence of prolonged air leak after lung resection in Japan.

Also known as: Neoveil

Reinforcement of air leak

Standard of care OTHER

Standard of care after air leak post lung resection

No reinforcement of air leak

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients undergoing emergency lung resection

Sponsors & Collaborators

• Boston Medical Center: lead
• Gunze Limited: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kei Suzuki, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 23, 2020
• Study Start: October 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)