Lung Diseases, Mesothelioma
Conditions
Keywords
Lung Diseases, Mesothelioma, Pleurectomy decortication, Progel, Talcum powder, Pain questionnaires, Surveys, Intraoperative air leaks, IAL
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.
Interventions
OTHERProgel Sealant
After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest.
OTHERTalcum Powder
After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest.
BEHAVIORALPain Questionnaire
Participants complete pain scale 3 times each day while in the hospital. Pain is rated on a pain scale of 0 - 10.
Sponsors
Bard Incorporated
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed