Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties

March 11, 2025 updated by: Vantive Health LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12101
        • St. Joseph-Krankenhaus Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
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).
Device: GamCath® central venous catheter
choice of catheter type
Other Names:
  • GamCath® catheter, No. CE 76891
Experimental: B
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).
Device: GamCath Dolphin® Protect central venous catheter
choice of catheter type
Other Names:
  • GamCath Dolphin® Protect, No.CE 90671

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bacterial colonisation of the catheter surface
Time Frame: at explantation
at explantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Surface deposits of thrombogenic activity
Time Frame: at explantation
at explantation
Catheter survival
Time Frame: at explantation
at explantation
Exit site appearance
Time Frame: at routine catheter care
at routine catheter care
Blood parameters
Time Frame: during dialysis
during dialysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vantive Health LLC

Collaborators

Baxter Healthcare Corporation
Gambro Dialysatoren GmbH

Investigators

  • Principal Investigator: Christiane M Erley, Prof. Dr., St. Joseph-Krankenhaus Berlin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 31, 2008

First Submitted That Met QC Criteria

February 21, 2008

First Posted (Estimated)

February 22, 2008

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Study No 2007_MBR_001
  • ISRCTN93939200 (Registry Identifier: ISRCTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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