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

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Diseases; Mesothelioma

Intervention: Progel Sealant (Other); Talcum Powder (Other); Pain Questionnaire (Behavioral)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Reza J. Mehran, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Overall contact:
Reza J. Mehran, MD, Phone: 713-745-4530

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.

Clinical Details

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

Primary outcome: Time to Resolve Air Lung Leak After 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 ProgelĀ® 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 ProgelĀ® 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 ProgelĀ® polyethylene glycol load

Locations and Contacts

Reza J. Mehran, MD, Phone: 713-745-4530

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Not yet recruiting
Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: December 2015
Last updated: July 29, 2015

Page last updated: August 23, 2015

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