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Effectiveness Novel Tissue Sealant, Prevention Prolonged Air Leak (PAL) After Lung Resection

NCT02491671 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2021-08-09

Study results available
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Summary

The effectiveness of tissue sealants to prevent Prolonged Air Leak (PAL) after lung resection procedures remains unproved. The investigators hypothesize that one of the main reasons for that is the heterogeneity of previously studied populations. Since currently the risk of postoperative PAL can be scored with a reasonable accuracy, the aim of this research is to investigate the effect of routine application of a novel tissue sealant in patients selected on the basis of a high risk of PAL estimated before surgery.

Conditions

  • Prolonged Air Leak
  • Lung Resection

Interventions

DEVICE

Hemopatch

PROCEDURE

standard preventive measures

Sponsors & Collaborators

  • Instituto de Investigación Biomédica de Salamanca

    collaborator OTHER

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

    lead OTHER

Principal Investigators

  • Gonzalo Varela, MD PhD FETCS · IBSAL-Instituto de Investigación Biomédica de Salamanca

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-24
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02491671 on ClinicalTrials.gov