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

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ClinicalTrials.gov Identifier: NCT04317924
Recruitment Status : Withdrawn (Resources not available to conduct the research.)
First Posted : March 23, 2020
Last Update Posted : August 26, 2020
Sponsor:
Collaborator:
Gunze Limited
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Air Leak From Lung Device: Polyglycolic acid felt Other: Standard of care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Use of Polyglycolic Acid Felt for Air-leak Prevention After Lung Resection
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

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 Name: 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients undergoing emergency lung resection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04317924


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Gunze Limited
Investigators
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Principal Investigator: Kei Suzuki, MD Boston Medical Center
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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT04317924    
Other Study ID Numbers: H-37652
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Boston Medical Center:
Pneumostasis
Bio-absorbable mesh
Lung resection
Neoveil