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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01511 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Bard Incorporated | UNKNOWN |
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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.
If participant agrees to take part in this study, they will have their pleurectomy decortication as planned. Participant will sign a separate consent for this procedure that explains the risks.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progel Sealant | Experimental | 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. |
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| Standard of Care | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progel Sealant | Other | After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Resolve Air Lung Leak After Pleurectomy Decortication | Primary outcome is T = time to resolve an air leak in the lungs, allowing the possibility that an air leak may not develop, represented by T=0. | Participants followed for the duration of hospital stay, at least 5 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reza J. Mehran, MD | M.D. Anderson Cancer Center | Principal Investigator |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D008654 | Mesothelioma |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D013627 | Talc |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D017633 | Magnesium Silicates |
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D017640 | Silicates |
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| Talcum Powder | Other | After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest. |
|
| Pain Questionnaire | Behavioral | Participants complete pain scale 3 times each day while in the hospital. Pain is rated on a pain scale of 0 - 10. |
|
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| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008903 |
| Minerals |
| D012824 | Silicic Acid |
| D012822 | Silicon Dioxide |
| D017655 | Silicon Compounds |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |