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Medixair® System on Surgical Site Infection in Cardiac Patients

NCT02492919 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2015-09-25

No results posted yet for this study

Summary

There is a growing incidence of sepsis and septic shock in people after surgery, for which there may be several reasons: more elderly people and more severe illnesses are entering operating theatres, more invasive systems are being used to take care of patients in intensive care units, etc... Sepsis and septic shock are the most prevalent illnesses which cause the highest mortality in intensive care units.

The incidence of this illness is 500,000 / year in the USA, and 240-400 / 100,000 persons in Europe. So this is a subject of great interest in hospitals and also to the National Health System (to both health workers and the health authorities) as a lot of money is spent on this illness.

Since the 19th century, ultraviolet rays have been known to be able to sterilize microorganisms (to kill them); yet no ultraviolet system machine has been on the market, until now, to control nosocomial infections.

The Medixair system, which aims to do this, has recently come on to the market. It uses C-ultraviolet rays, which are the strongest kind of ultraviolet rays to kill microorganisms.

Thus, it is of interest to know whether this system is good enough to lower infections in intensive care units. It is logical to believe that the the fewer the micro-organisms, the lower the possibilities of infection.

Conditions

  • Surgical Site Infection

Interventions

DEVICE

Medixair®

Medixair system uses C-ultraviolet rays, which are the strongest ultraviolet kind of rays to kill microorganisms. The intervention consist consists of adding the Medixair® device, to be various beds of Cardiac Reanimation Units, or not.

Sponsors & Collaborators

  • Hospital Clínico Universitario de Valladolid

    collaborator OTHER

  • University of Valladolid

    lead OTHER

Principal Investigators

  • Eduardo Tamayo, PhD, MD · Hospital Clínico Universitario de Valladolid

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-01-31
Completion
2015-01-31

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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 NCT02492919 on ClinicalTrials.gov