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Comparison of Central Venous Catheters With Silver Nanoparticles Versus Conventional Catheters

NCT00337714 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 472

Last updated 2011-05-16

No results posted yet for this study

Summary

Bloodstream infections are common in Intensive Care Units (ICUs). The need of a central venous line increases the risk of bacteremia and central venous catheter (CVC) related infections. The use of catheters coated and/or impregnated with different antimicrobial agents has been proposed to reduce the risk of such infections. However, results obtained so far did not reach enough clinical relevance to consider these medicated catheters as a valid alternative to the conventional ones.

The aim of this comparative randomized study is to assess the ability of recently developed silver ion-releasing central venous catheters in preventing associated infections in comparison with the conventional ones.

Experimental groups are defined as follows:

* Group A: patients treated with standard, triple lumen, non medicated catheters
* Group B: patients treated with triple lumen catheters impregnated with silver nanoparticles

Conditions

  • Central Venous Catheter Related Infections

Interventions

PROCEDURE

CVC impregnated with silver nanoparticles (AgTive®)

insertion of medicated silver nanoparticles CVC

PROCEDURE

CVC cannulation

placement of conventional trilumen CVCs

Sponsors & Collaborators

  • ISS, Dip.Tecnologie e Salute, Prof. Gianfranco Donelli

    collaborator UNKNOWN

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Massimo Antonelli, Prof · Catholic University of the Sacred Heart

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Completion
2008-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00337714 on ClinicalTrials.gov