Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties

Not Applicable

Completed

• Conditions: Renal Insufficiency
• Interventions: Device: GamCath Dolphin® Protect central venous catheter; Device: GamCath® central venous catheter

• Registration Number: NCT00621712
• Lead Sponsor: Vantive Health LLC

Brief 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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-22
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	GamCath Dolphin® Protect central venous catheter	Patients in group B will be treated with a CE certified double lumen catheter with a new antibacterial bismuth-containing surface coating (GamCath Dolphin® Protect, No. CE 90671).
A	GamCath® central venous catheter	Patients in group A will be provided with a commercially available and CE certified standard double lumen catheter without surface coating (GamCath® catheter, No. CE 76891).

Primary Outcome Measures

Name	Time	Method
Bacterial colonisation of the catheter surface	at explantation

Secondary Outcome Measures

Name	Time	Method
Blood parameters	during dialysis
Catheter survival	at explantation
Surface deposits of thrombogenic activity	at explantation
Exit site appearance	at routine catheter care

Trial Locations

Locations (1)

St. Joseph-Krankenhaus Berlin; 🇩🇪 Berlin, Germany