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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02511600
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact
Status	Withdrawn
Phase	Phase 3
Start date	December 2015

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms