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

Phase 3

Withdrawn

• Conditions: Lung Diseases; Mesothelioma
• Interventions: Other: Progel Sealant; Other: Talcum Powder; Behavioral: Pain Questionnaire

• Registration Number: NCT02511600
• Lead Sponsor: M.D. Anderson Cancer Center

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 Timeline

• Study First Submitted: 2015-07-28
• Study First Submitted QC: 2015-07-29
• Study First Posted: 2015-07-30
• Status Verified: 2015-12
• Study Start: 2015-12
• Last Update Submitted: 2015-12-14
• Last Update Posted: 2015-12-15
• Primary Completion: 2018-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Pain Questionnaire	After pleurectomy decortication, talcum powder 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.
Progel Sealant	Progel Sealant	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.
Progel Sealant	Pain Questionnaire	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.
Standard of Care	Talcum Powder	After pleurectomy decortication, talcum powder 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.

Primary Outcome Measures

Name	Time	Method
Time to Resolve Air Lung Leak After Pleurectomy Decortication	Participants followed for the duration of hospital stay, at least 5 days.	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.