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Comparison of Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication

NCT02511600 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-12-15

No results posted yet for this study

Summary

The goal of this clinical research study is to compare Progel® (a type of surgical sealant that is made from human blood products) to the standard of care (talcum powder) to learn if one method is better than the other for preventing air leaks in patients having a pleurectomy decortication.

Conditions

Interventions

OTHER

Progel Sealant

After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest.

OTHER

Talcum Powder

After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest.

BEHAVIORAL

Pain Questionnaire

Participants complete pain scale 3 times each day while in the hospital. Pain is rated on a pain scale of 0 - 10.

Sponsors & Collaborators

  • Bard Incorporated

    collaborator UNKNOWN

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Reza J. Mehran, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-12-31

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Diseases

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 NCT02511600 on ClinicalTrials.gov