search
Back to results

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

Primary Purpose

Lung Diseases, Mesothelioma

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Progel Sealant
Talcum Powder
Pain Questionnaire
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases focused on measuring Lung Diseases, Mesothelioma, Pleurectomy decortication, Progel, Talcum powder, Pain questionnaires, Surveys, Intraoperative air leaks, IAL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Progel Sealant

    Standard of Care

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 28, 2015
    Last Updated
    December 14, 2015
    Sponsor
    M.D. Anderson Cancer Center
    Collaborators
    Bard Incorporated
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02511600
    Brief Title
    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

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    December 2015 (undefined)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    M.D. Anderson Cancer Center
    Collaborators
    Bard Incorporated

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Diseases, Mesothelioma
    Keywords
    Lung Diseases, Mesothelioma, Pleurectomy decortication, Progel, Talcum powder, Pain questionnaires, Surveys, Intraoperative air leaks, IAL

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Progel Sealant
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Standard of Care
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Progel Sealant
    Intervention Description
    After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest.
    Intervention Type
    Other
    Intervention Name(s)
    Talcum Powder
    Intervention Description
    After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pain Questionnaire
    Other Intervention Name(s)
    Survey
    Intervention Description
    Participants complete pain scale 3 times each day while in the hospital. Pain is rated on a pain scale of 0 - 10.
    Primary Outcome Measure Information:
    Title
    Time to Resolve Air Lung Leak After Pleurectomy Decortication
    Description
    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.
    Time Frame
    Participants followed for the duration of hospital stay, at least 5 days.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients with mesothelioma or other pathologies undergoing a pleurectomy decortication at MD Anderson Cancer Center Adequate preoperative renal function documented by serum creatinine of < 1.5 mg/dl or calculated creatinine clearance > 50 ml/min Exclusion Criteria: Patients unable to consent for the procedure Patients with a history of allergy to human proteins Patients who may have insufficient renal capacity for clearance of Progel® polyethylene glycol load
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Reza J. Mehran, MD
    Organizational Affiliation
    M.D. Anderson Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.mdanderson.org
    Description
    University of Texas MD Anderson Cancer Center Website

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs