Comparison of Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Lung Cancer, Cancer, Pulmonary |
| Therapuetic Areas: | Oncology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/12/2015 |
| Start Date: | December 2015 |
| Contact: | Reza J. Mehran, MD |
| Phone: | 713-745-4530 |
A Randomized Phase III Trial to Compare the Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication for Mesothelioma or Other Pathologies
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.
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:
- 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.
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.
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
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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