NCT00621114

Ex Vivo Microbiological Assessment of an Anti-biofilm Catheter in Acute Dialysis Application

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The clinical study aims at providing data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections of a catheter with antibacterial surface coating in comparison to standard catheters without coating.

Detailed description

Central venous catheters are increasingly used to provide long-term venous access, e.g. after failure of the primary arteriovenous fistula, and they are the first choice in case of an acute need for extracorporeal therapy. Microbial adhesions and biofilm formation have been implicated in serious infections associated with the use of indwelling catheters. In view of the necessity to reduce catheter-related bloodstream infections and of the inadequacy of currently available antimicrobially coated devices, a new antimicrobial catheter surface was developed. The clinical study described below aims at providing further data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections.

Conditions

• Hemodialysis

Interventions

Type	Name	Description
DEVICE	GamCath® central venous catheter	Choice of central venous catheter type
DEVICE	GamCath Dolphin® Protect central venous catheter	Choice of central venous catheter type

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-02-22
• Last updated: 2025-03-13

Locations

1 site across 1 country: Germany