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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Time to Resolve Air Lung Leak After Pleurectomy Decortication
Condition
Lung Diseases
Intervention
Progel Sealant
Study Arms / Comparison Groups
Progel Sealant
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
0
Start Date
December 2015
Primary Completion Date
December 2018
Eligibility Criteria
Inclusion Criteria:
1. All patients with mesothelioma or other pathologies undergoing a pleurectomy
decortication at MD Anderson Cancer Center
2. Adequate preoperative renal function documented by serum creatinine of < 1.5 mg/dl or
calculated creatinine clearance > 50 ml/min
Exclusion Criteria:
1. Patients unable to consent for the procedure
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Reza J. Mehran, MD, ,
Administrative Informations
NCT ID
NCT02511600
Organization ID
2014-0958
Secondary IDs
NCI-2015-01511
Responsible Party
Sponsor
Study Sponsor
M.D. Anderson Cancer Center
Collaborators
Bard Incorporated
Study Sponsor
Reza J. Mehran, MD, Principal Investigator, M.D. Anderson Cancer Center
Verification Date
December 2015