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

Lung Diseases Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02511600
• Other study ID #: 2014-0958
• Secondary ID: NCI-2015-01511
• Status: Withdrawn
• Phase: Phase 3
• First received: July 28, 2015
• Last updated: December 14, 2015
• Start date: December 2015

Study information

• Verified date: December 2015
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lung Diseases
• Mesothelioma

Intervention

Other:
• Progel Sealant
After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest.
• Talcum Powder
After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest.

Behavioral:
• Pain Questionnaire
Participants complete pain scale 3 times each day while in the hospital. Pain is rated on a pain scale of 0 - 10.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Bard Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Participants followed for the duration of hospital stay, at least 5 days.	No

External Links

•   University of Texas MD Anderson Cancer Center Website