Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-12-31

Brief Summary

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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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Detailed Description

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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

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Renal Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

GamCath® central venous catheter

Intervention Type DEVICE

choice of catheter type

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).

Group Type EXPERIMENTAL

GamCath Dolphin® Protect central venous catheter

Intervention Type DEVICE

choice of catheter type

Interventions

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GamCath® central venous catheter

choice of catheter type

Intervention Type DEVICE

GamCath Dolphin® Protect central venous catheter

choice of catheter type

Intervention Type DEVICE

Other Intervention Names

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GamCath® catheter, No. CE 76891 GamCath Dolphin® Protect, No.CE 90671

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No