Comparison of Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication
NCT ID: NCT02511600
Last Updated: 2015-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2015-12-31
Brief Summary
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Detailed Description
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At the time of participant's surgery, sutures and staples are used to help correct air leaks, which is standard.
Then, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group:
* One group will have Progel® added to the surface of the lung before closing the chest.
* The other group will have talcum powder added to the surface of the lung before closing the chest.
Participant will have an equal chance of being in either group.
During the surgery, air leaks will be checked electronically and that information will be recorded.
After surgery, participant will be asked to rate their pain on a pain scale of 0-10. Participant will be asked to complete this pain scale 3 times each day while they are in the hospital.
Length of Study Participation:
After participant's surgery and their air leak is resolved, their participation in this study will be over.
This is an investigational study. The Progel® surgical sealant is FDA approved for the control of air leaks during lung surgery. It is investigational to compare the surgical sealant with the standard-of-care (talcum powder) to learn if it can reduce the number of days in the hospital after surgery.
Up to 48 participants will enrolled in this study. All will take part at MD Anderson.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Progel Sealant
After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest. Participants complete pain scale 3 times each day while in the hospital.
Progel Sealant
After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest.
Pain Questionnaire
Participants complete pain scale 3 times each day while in the hospital. Pain is rated on a pain scale of 0 - 10.
Standard of Care
After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest. Participants complete pain scale 3 times each day while in the hospital.
Talcum Powder
After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest.
Pain Questionnaire
Participants complete pain scale 3 times each day while in the hospital. Pain is rated on a pain scale of 0 - 10.
Interventions
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Progel Sealant
After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest.
Talcum Powder
After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest.
Pain Questionnaire
Participants complete pain scale 3 times each day while in the hospital. Pain is rated on a pain scale of 0 - 10.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Adequate preoperative renal function documented by serum creatinine of \< 1.5 mg/dl or calculated creatinine clearance \> 50 ml/min
Exclusion Criteria
2. Patients with a history of allergy to human proteins
3. Patients who may have insufficient renal capacity for clearance of Progel® polyethylene glycol load
18 Years
ALL
No
Sponsors
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Bard Incorporated
UNKNOWN
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Reza J. Mehran, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2015-01511
Identifier Type: REGISTRY
Identifier Source: secondary_id
2014-0958
Identifier Type: -
Identifier Source: org_study_id