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The purpose of this study is to evaluate the safety and effectiveness of port (PAC) flushes every 3 months rather than every four to six weeks.
It is routine practice to flush ports every four to six weeks, according to the manufacturer's recommendations, using 10cc (two teaspoons) of salt solution, followed by 5 cc (one teaspoon) of heparin, if needed. This procedure takes between 5-10 minutes.
However, as a participant in this research study, your port will be flushed every three months, using routine sterile precautions and techniques (sterile gloves, disinfectant solution used to prep the skin around the port and insertion site and a sterile drape to cover the area).
This is a Phase II trial, non-blinded, non-inferiority prospective cohort study on patients with PAC after systemic therapy to evaluate the safety and effectiveness of PAC flushes in 3 months intervals. The study will span over 1 year from last enrolled patient, and each patient will get five flushes in 3 months interval. The incidence of end points of the study would be determined from patients' medical records. Patient with cancer of all variety will be followed after curative intent therapy.
Patients will be enrolled after the completion of systemic therapy and after completion of the restaging follow up, which is the time period from 4 weeks to 3 months after discontinuation of the chemotherapy. Once patients are enrolled to extended interval PAC flushes they will be followed for one year. At the end of the year patients will return to standard PAC flushes.
Informed consent will be obtained by institutional guidelines; the catheter will be flushed on that same day regardless of prior flush schedule. Thereafter patient will have a schedule of four additional PAC flushes in 3 months interval, which would coincide with follow up visit to see the physician. If patients develop any PAC malfunction event, that would be considered a PAC failure, and subsequently would be reverted back to the protocol recommended by the manufacturer.
Patients treated by the Department of Medical Oncology and Hematology at the James Graham Brown Cancer Center, University of Louisville will be screened and all eligible patients will be consented.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Patients With Catheters/Ports Receiving Chemotherapy
James Graham Brown Cancer Center
James Graham Brown Cancer Center
Published on BioPortfolio: 2014-07-23T21:11:09-0400
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