Medixair® System on Surgical Site Infection in Cardiac Patients

NCT02492919 | Completed

• 2 other identifiers: PI 14-17617-01-2011
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

cardiac surgery; risk factors; infection

Outcome Measures

Primary Outcomes (1)

• Infection rates after cardiac surgery

  To assess if there are fewer catheter infections, less bacteraemia, fewer urinary infections, fewer surgery site infections, fewer pneumonias in patients who have spent their first days after a heart surgery in a box with the Medixair system than without it.

  3 weeks

Secondary Outcomes (3)

• Number of infected patients

  3 weeks

• mortality rate

  3 weeks and for the whole stay at hospital

• number of patients with pneumonia

  3 weeks

Study Arms (2)

Medixair®

EXPERIMENTAL

Cardiac reanimation unit bed with Medixair®

Device: Medixair®

NO Medixair®

NO INTERVENTION

Cardiac reanimation unit bed with NO Medixair®

Interventions

Medixair® DEVICE

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.

Medixair®

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to Postoperative Cardiac Intensive Care Unit after Cardiac Surgery with Extracorporeal Circulation

You may not qualify if:

• Not signing informed consent

Sponsors & Collaborators

• University of Valladolid: lead
• Hospital Clínico Universitario de Valladolid: collaborator

MeSH Terms

Conditions

Surgical Wound Infection; Infections

Condition Hierarchy (Ancestors)

Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eduardo Tamayo, PhD, MD

  Hospital Clínico Universitario de Valladolid

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: July 9, 2015
• Study Start: January 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: September 25, 2015

Record last verified: 2015-09