Surgical Site InfectionNCT02492919
Medixair® System on Surgical Site Infection in Cardiac Patients
A study testing Medixair® in people with Surgical Site Infection, run by University of Valladolid.
Trial 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... Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Medixair®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to Postoperative Cardiac Intensive Care Unit after Cardiac Surgery with Extracorporeal Circulation
Who cannot join
- Not signing informed consent
About this study
Official title: Impact of Medixair® System on Surgical Site Infection in Patients Admitted Into the Postoperative Cardiac Intensive Care Unit
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.
Read more
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.
Read the detailed description
Study design Prospective, comparative, randomized, non intervention study
Patients
Patients older than 18 years
Cardiac Surgery anesthetized using Extracorporeal Circulation
Randomization
There are 10 independent boxes at the Postoperative Cardiac Intensive Care Unit. (Each of these boxes have single beds). Every year, the Cardiac Reanimation Unit of our hospital received 500 patients, post heart surgery.
After getting the permissions needed to make the research, the Medixair® system has been placed in 5 of these units, and the comparison group will be the other 5 beds without Medixair®. Patients have been assigned randomly to either (Medixair® and NO Medixair®).
The endpoint is:
-To compare the infection rates after a cardiac surgery, on patients located in boxes with and without a Medixair® system.
The aim is to see if there are fewer catheter infections, less bacteraemia, fewer urinary infections, less site of surgery infections, and fewer pneumonias in patients who have spent their first days after a heart surgery in a box with Medixair® system than without it. The infection rates in the intensive care unit will be followed, as well as the whole stay at hospital, as there might be fewer infections if there were fewer microorganisms around.
Other objectives are:
- Identifying preoperative, intraoperative and postoperative risk factors to develop an infection illness after cardiac surgery, as well as which increase the length of stay at hospital and the mortality rate.
- Making an economic study of using this system against not using it.
A further aim is to measure the following variables:
- Dependent variables (Outcome variables): infection
- 2º Outcome variables: colonization
- Independent variables will be a risk factor for infection:
- Preoperative: age, sex, any preoperative illness, immunosuppressor treatment, including corticosteroids.
- Intraoperative: antibiotic prophylaxis, surgical technique, length of cardiopulmonary bypass, length of aorta clamped, temperature during cardiopulmonary bypass, hematocrit at the end of cardiopulmonary bypass.
- Postoperative: length with mechanical ventilation, time spent in hospital, time spent in an intensive care unit, any organ complication (pulmonary insufficiency, renal failure, low cardiac index), septicemia, invasive techniques used, positive microorganism cultures.
All of the patients will be treated in the same way
Estimated number of patients
Nowadays, the infection rate after cardiac surgery is around 5%, so following the current hypothesis that the Medixair® system, because of its ultraviolet emissions, is going to lower the infection rate after cardiac surgery, 419 patients are needed in each group to be able to demonstrate a significative 5% reduction in infection rates, with an alpha error of 0.05 and a beta error of 0.2 to have a power of 80%.
As this is a preliminary study, in order to demonstrate a 5% reduction in the infection rate, half the number of patients (half of 419) will be used. As the patient volume is 500 a year, the number will be rounded up to 500, in order to be able to consider a complete year.
- Conditions
- Surgical Site Infection
- Being tested
- Medixair®
- Keywords
- cardiac surgery, risk factors, infection
- Medical subject headings
- Surgical Wound Infection, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Medixair® | Experimental | Cardiac reanimation unit bed with Medixair® Receives: Device: Medixair® |
| NO Medixair® | No intervention | Cardiac reanimation unit bed with NO Medixair® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (3)
Number of infected patients
Number of infected patients
Measured: 3 weeks
mortality rate
mortality rate
Measured: 3 weeks and for the whole stay at hospital
number of patients with pneumonia
number of patients with pneumonia
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startJan 2011
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valladolid
- Responsible party
- Principal investigator, F. Javier Alvarez, University of Valladolid
- Investigators
- Eduardo Tamayo, PhD, MD, Study director, Hospital Clínico Universitario de Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492919
- Sponsor's protocol ID
- PI 14-176
- Other IDs
- 17-01-2011
- Status last verified
- Sep 2015
- First submitted
- 4 May 2015
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Medixair® System on Surgical Site Infection in Patients Admitted Into the Postoperative Cardiac Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02492919
- Acronym / sponsor ID
- PI 14-176
- Conditions
- Surgical Site Infection
- Keywords
- cardiac surgery, risk factors, infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valladolid
- Study start
- Jan 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design Prospective, comparative, randomized, non intervention study
Patients
Patients older than 18 years
Cardiac Surgery anesthetized using Extracorporeal Circulation
Randomization
There are 10 independent boxes at the Postoperative Cardiac Intensive Care Unit. (Each of these boxes have single beds). Every year, the Cardiac Reanimation Unit of our hospital received 500 patients, post heart surgery.
After getting the permissions needed to make the research, the Medixair® system has been placed in 5 of these units, and the comparison group will be the other 5 beds without Medixair®. Patients have been assigned randomly to either (Medixair® and NO Medixair®).
The endpoint is:
-To compare the infection rates after a cardiac surgery, on patients located in boxes with and without a Medixair® system.
The aim is to see if there are fewer catheter infections, less bacteraemia, fewer urinary infections, less site of surgery infections, and fewer pneumonias in patients who have spent their first days after a heart surgery in a box with Medixair® system than without it. The infection rates in the intensive care unit will be followed, as well as the whole stay at hospital, as there might be fewer infections if there were fewer microorganisms around.
Other objectives are:
- Identifying preoperative, intraoperative and postoperative risk factors to develop an infection illness after cardiac surgery, as well as which increase the length of stay at hospital and the mortality rate.
- Making an economic study of using this system against not using it.
A further aim is to measure the following variables:
- Dependent variables (Outcome variables): infection
- 2º Outcome variables: colonization
- Independent variables will be a risk factor for infection:
- Preoperative: age, sex, any preoperative illness, immunosuppressor treatment, including corticosteroids.
- Intraoperative: antibiotic prophylaxis, surgical technique, length of cardiopulmonary bypass, length of aorta clamped, temperature during cardiopulmonary bypass, hematocrit at the end of cardiopulmonary bypass.
- Postoperative: length with mechanical ventilation, time spent in hospital, time spent in an intensive care unit, any organ complication (pulmonary insufficiency, renal failure, low cardiac index), septicemia, invasive techniques used, positive microorganism cultures.
All of the patients will be treated in the same way
Estimated number of patients
Nowadays, the infection rate after cardiac surgery is around 5%, so following the current hypothesis that the Medixair® system, because of its ultraviolet emissions, is going to lower the infection rate after cardiac surgery, 419 patients are needed in each group to be able to demonstrate a significative 5% reduction in infection rates, with an alpha error of 0.05 and a beta error of 0.2 to have a power of 80%.
As this is a preliminary study, in order to demonstrate a 5% reduction in the infection rate, half the number of patients (half of 419) will be used. As the patient volume is 500 a year, the number will be rounded up to 500, in order to be able to consider a complete year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medixair® | Experimental | Device: Medixair®Cardiac reanimation unit bed with Medixair® |
| NO Medixair® | No intervention | –Cardiac reanimation unit bed with NO Medixair® |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to Postoperative Cardiac Intensive Care Unit after Cardiac Surgery with Extracorporeal Circulation
Key exclusion criteria (1 listed)
- Not signing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Medixair® |
Primary outcome
Infection rates after cardiac surgery
Time frame: 3 weeks
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 secondary outcomes
Number of infected patients
Time frame: 3 weeks
mortality rate
Time frame: 3 weeks and for the whole stay at hospital
number of patients with pneumonia
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Tamayo, PhD, MD study director
Hospital Clínico Universitario de Valladolid
Questions about this trial
What is this clinical trial studying?
A study testing Medixair® in people with Surgical Site Infection, run by University of Valladolid.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection rates after cardiac surgery (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2015.