Maintenance Optimization of the Fully Implanted Venous Catheter

Condition(s) studied

Investigational drug(s) / intervention(s)

Saline solution maintenance of the CVC: Saline solution maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B\|Braun, according to local standard procedures.

No maintenance of the CVC: No maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B\|Braun. Just visual inspection to local site of CVC insertion.

Study summary

Central venous catheter (CVC) are intravascular devices used in clinical practice, namely to administer fluid therapy, parenteral nutrition, drugs, blood products, hemodynamic monitoring, also being a gateway to the collection of blood samples or laboratory monitoring.

The fully implanted central venous catheter (CVCTI) is a type of central venous access surgically placed, which is characterized by containing a subcutaneous reservoir that is accessed by puncturing the camera with a blunt needle, widely used in cancer patients. The fully implanted central venous catheter is recommended when there is a need for intermittent vascular access and of long duration.

The maintenance of the CVCTI, as it's the necessity, frequency, and method is subject of some controversy, with discrepancies between the various cancer centers and guidance documents, once they occur several different intervals and maintenance methods.

The objective of this study is to assess the necessity of frequent maintenance of fully implanted central venous catheter, still assuring its viability and holding the same or lower number incidence of complications.

Participants in this study are cancer patients with a CVC fully implanted for chemotherapy, in follow-up phase. Participants will be randomized in one of two arms: Maintenance with saline solution and no maintenance.

Eligibility

Primary outcome measure(s)

• Number of Adverse Events — Time since screening until follow-up visit (on average 20 months)
  The occurrence of any adverse event related to the use of the CVCTI, thus allowing to assess the difference between the 2 groups with as much data as possible.

Trial sites (1)

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