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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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.

Official Title
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A Randomized Phase III Trial to Compare the Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication for Mesothelioma or Other Pathologies

Conditions
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Mesothelioma, Lung Diseases

Intervention / Treatment
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* Other: Progel Sealant
* Other: Talcum Powder
* Behavioral: Pain Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with mesothelioma or other pathologies undergoing a pleurectomy decortication at MD Anderson Cancer Center Adequate preoperative renal function documented by serum creatinine of < 1.5 mg/dl or calculated creatinine clearance > 50 ml/min Exclusion Criteria: Patients unable to consent for the procedure Patients with a history of allergy to human proteins Patients who may have insufficient renal capacity for clearance of Progel® polyethylene glycol load

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progel Sealant<br>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. | Other: Progel Sealant<br>* After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest.<br>Behavioral: Pain Questionnaire<br>* Participants complete pain scale 3 times each day while in the hospital. Pain is rated on a pain scale of 0 - 10.<br>* Other names: Survey;|
| Active Comparator: Standard of Care<br>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. | Other: Talcum Powder<br>* After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest.<br>Behavioral: Pain Questionnaire<br>* Participants complete pain scale 3 times each day while in the hospital. Pain is rated on a pain scale of 0 - 10.<br>* Other names: Survey;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Progel, Lung Diseases, Mesothelioma, Pleurectomy decortication, Talcum powder, Pain questionnaires, Surveys, Intraoperative air leaks, IAL