Comparison of Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication
Primary Purpose
Lung Diseases, Mesothelioma
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Progel Sealant
Talcum Powder
Pain Questionnaire
Sponsored by
About this trial
This is an interventional treatment trial for Lung Diseases focused on measuring Lung Diseases, Mesothelioma, Pleurectomy decortication, Progel, Talcum powder, Pain questionnaires, Surveys, Intraoperative air leaks, IAL
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Progel Sealant
Standard of Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02511600
First Posted
July 28, 2015
Last Updated
December 14, 2015
Sponsor
M.D. Anderson Cancer Center
Collaborators
Bard Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT02511600
Brief Title
Comparison of Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication
Official Title
A Randomized Phase III Trial to Compare the Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication for Mesothelioma or Other Pathologies
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Bard Incorporated
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Mesothelioma
Keywords
Lung Diseases, Mesothelioma, Pleurectomy decortication, Progel, Talcum powder, Pain questionnaires, Surveys, Intraoperative air leaks, IAL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Progel Sealant
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Progel Sealant
Intervention Description
After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest.
Intervention Type
Other
Intervention Name(s)
Talcum Powder
Intervention Description
After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest.
Intervention Type
Behavioral
Intervention Name(s)
Pain Questionnaire
Other Intervention Name(s)
Survey
Intervention Description
Participants complete pain scale 3 times each day while in the hospital. Pain is rated on a pain scale of 0 - 10.
Primary Outcome Measure Information:
Title
Time to Resolve Air Lung Leak After Pleurectomy Decortication
Description
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.
Time Frame
Participants followed for the duration of hospital stay, at least 5 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza J. Mehran, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website
Learn more about this trial
Comparison of Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication
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