NCT00621712

Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties

Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties: Efficacy and Effect of Intensive Catheter and Exit Site Care Education

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study investigates the efficacy of a catheter with antibacterial surface coating in preventing central venous catheter related infection and the effect of an intensive hygiene and catheter care education of the nursing staff on preventing central venous catheter-related infection.

Detailed description

The risk of catheter-related bloodstream infection depends on catheter type, method and site of insertion, aseptic technique and number of manipulations. To address this problem, efforts have focused on engineering biomaterials and surfaces with antibacterial properties to prevent bacteria adhesion and biofilm formation. 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. Among other factors, the mode and quality of catheter handling and care of exit site is an important aspect with respect to catheter-related infections. The clinical study aims at providing data on antimicrobial efficiency of the 2 types of CE certified double lumen catheters and a supposed additional preventive effect of intense hygiene training on catheter-related infections.

Conditions

• Renal Insufficiency

Interventions

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

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-02-22
• Last updated: 2025-03-13

Locations

1 site across 1 country: Germany