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Completed

NCT Number: NCT00621712

Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph-Krankenhaus Berlin

Berlin, 12101, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • central venous catheter placement
  • Need for extracorporeal renal replacement therapy (acute and chronic renal failure)
  • Age over 18 years
  • Written informed consent
  • Needed catheter length 15 cm or 20 cm

Exclusion criteria

  • Known infectivity with Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV)
  • Any infection associated with one or more positive blood cultures within 10 days prior to catheter implantation
  • Bacteremia with a former catheter within 10 days prior to catheter implantation
  • Known pregnancy
  • Lactation
  • Participation in another clinical study during the preceding 30 days

Treatment and study plan

GamCath® central venous catheter

Device

choice of catheter type

Other names: GamCath® catheter, No. CE 76891

GamCath Dolphin® Protect central venous catheter

Device

choice of catheter type

Other names: GamCath Dolphin® Protect, No.CE 90671

Primary outcomes

  1. Bacterial colonisation of the catheter surface

    Time frame: at explantation

Secondary outcomes

  1. Surface deposits of thrombogenic activity

    Time frame: at explantation

  2. Catheter survival

    Time frame: at explantation

  3. Exit site appearance

    Time frame: at routine catheter care

  4. Blood parameters

    Time frame: during dialysis

Sponsors and collaborators

Lead sponsor

Vantive Health LLC

Industry

Collaborators

  • Baxter Healthcare Corporation
  • Gambro Dialysatoren GmbH

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 22, 2008
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.