Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties

Renal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621712
• Other study ID #: Study No 2007_MBR_001
• Secondary ID: ISRCTN93939200
• Status: Completed
• Phase: N/A
• First received: January 31, 2008
• Last updated: April 19, 2017
• Start date: October 2007
• Est. completion date: December 2010

Study information

• Verified date: March 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Device:
• GamCath® central venous catheter
choice of catheter type
• GamCath Dolphin® Protect central venous catheter
choice of catheter type

Locations

Country	Name	City	State
Germany	St. Joseph-Krankenhaus Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Gambro Dialysatoren GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial colonisation of the catheter surface		at explantation
Secondary	Surface deposits of thrombogenic activity		at explantation
Secondary	Catheter survival		at explantation
Secondary	Exit site appearance		at routine catheter care
Secondary	Blood parameters		during dialysis