Clinical trial NCT02511600: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Lung Diseases
Mesothelioma
Keywords: Lung Diseases
Mesothelioma
Pleurectomy decortication
Progel
Talcum powder
Pain questionnaires
Surveys
Intraoperative air leaks
IAL
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Bard Incorporated
First posted: 2015-07-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to Resolve Air Lung Leak After Pleurectomy Decortication
timeFrame: Participants followed for the duration of hospital stay, at least 5 days.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Reza J. Mehran, MD
role: PRINCIPAL_INVESTIGATOR
References: