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Complication of Catheter | Port Will be Flushed Every 3 Months Instead of Every 4-6 Wks, as Recommended by Port Manufacturer.

Complication of Catheter research study

What is the primary objective of this study?

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 salt solution followed heparin if needed. This study examines the effectiveness of port flushes at an alternative interval of 3 months, reducing the number of visits to the health-care provider.

Who is eligible to participate?

Inclusion Criteria: 1. All patients 18 years and older with solid or hematological tumor who have a PAC after completion of curative intent treatment (Chemotherapy/Biotherapy) 2. Without active disease 3. Able to give informed consent Exclusion Criteria: 1. Minors, prisoners 2. Previous PAC failure 3. Disease recurrence 4. Patients who had their PAC removed immediately following therapy.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Complication of Catheter

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Reduced port-flush schedule3-month port-flushing

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

3-month flushing schedule3-month port-flushing schedule

Study Status

Recruiting

Start Date: March 2009

Completed Date: December 2018

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Time to port complication

Secondary Outcome: Frequency and severity of toxicity

Study sponsors, principal investigator, and references

Principal Investigator: Goetz H Kloecker, MD

Lead Sponsor: James Graham Brown Cancer Center

Collaborator: University of Louisville

More information:https://clinicaltrials.gov/show/NCT01047644

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