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

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ClinicalTrials.gov Identifier: NCT02511600
Recruitment Status : Withdrawn
First Posted : July 30, 2015
Last Update Posted : December 15, 2015
Sponsor:
Collaborator:
Bard Incorporated
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lung Diseases Mesothelioma Other: Progel Sealant Other: Talcum Powder Behavioral: Pain Questionnaire Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2015
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arm Intervention/treatment
Experimental: 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.
Other: Progel Sealant
After pleurectomy decortication, Progel® sealant 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.
Other Name: Survey

Active Comparator: Standard of Care
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.
Other: 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.
Other Name: Survey




Primary Outcome Measures :
  1. Time to Resolve Air Lung Leak After Pleurectomy Decortication [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02511600


Sponsors and Collaborators
M.D. Anderson Cancer Center
Bard Incorporated
Investigators
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Principal Investigator: Reza J. Mehran, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02511600     History of Changes
Other Study ID Numbers: 2014-0958
NCI-2015-01511 ( Registry Identifier: NCI CTRP )
First Posted: July 30, 2015    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015
Keywords provided by M.D. Anderson Cancer Center:
Lung Diseases
Mesothelioma
Pleurectomy decortication
Progel
Talcum powder
Pain questionnaires
Surveys
Intraoperative air leaks
IAL
Additional relevant MeSH terms:
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Mesothelioma
Lung Diseases
Respiratory Tract Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial