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

August 24, 2020 updated by: Boston Medical Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients undergoing emergency lung resection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reinforcement of air leak
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
Neoveil is a polyglycolic acid felt that has been shown to decrease the incidence of prolonged air leak after lung resection in Japan.
Other Names:
  • Neoveil
Active Comparator: No reinforcement of air leak
Participants in this arm will receive standard of care for air leak post lung resection.
Other: Standard of care
Standard of care after air leak post lung resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to removal of chest tubes
Time Frame: 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.
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Collaborators

Gunze Limited

Investigators

  • Principal Investigator: Kei Suzuki, MD, Boston Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

March 20, 2020

First Posted (Actual)

March 23, 2020

Study Record Updates

Last Update Posted (Actual)

August 26, 2020

Last Update Submitted That Met QC Criteria

August 24, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-37652

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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