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Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties

2014-08-27 03:32:44 | BioPortfolio

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Conditions

Hemodialysis

Intervention

GamCath® central venous catheter, GamCath Dolphin® Protect central venous catheter

Location

St. Joseph-Krankenhaus Berlin
Berlin
Germany
12101

Status

Recruiting

Source

Gambro Dialysatoren GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:32:44-0400

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Central venous access.

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Medical and Biotech [MESH] Definitions

Placement of an intravenous catheter in the subclavian, jugular, or other central vein for central venous pressure determination, chemotherapy, hemodialysis, or hyperalimentation.

The blood pressure in the central large VEINS of the body. It is distinguished from peripheral venous pressure which occurs in an extremity.

A vascular anomaly characterized by a radial or wedge-shaped arrangement of dilated VEINS draining into a larger vein in the brain, spinal cord, or the meninges. Veins in a venous angioma are surrounded by normal nervous tissue, unlike a CENTRAL NERVOUS SYSTEM CAVERNOUS HEMANGIOMA that lacks intervening nervous tissue. Drainage of venous angioma is fully integrated with the body's venous system, therefore, in most cases there is no clinical signs and rare bleeding.

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Catheters that are inserted into a large central vein such as a SUBCLAVIAN VEIN or FEMORAL VEIN.

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