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Evaluation of Peri-operative Risk Factors for Surgery Site Infection in Cardiac Surgery (PRISCCA)

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ClinicalTrials.gov Identifier: NCT02392936
Recruitment Status : Unknown
Verified March 2015 by Paul-Henri WICKY, Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Not yet recruiting
First Posted : March 19, 2015
Last Update Posted : March 19, 2015
Sponsor:
Information provided by (Responsible Party):
Paul-Henri WICKY, Centre Hospitalier Universitaire de Besancon

Brief Summary:

There is a recent increase in incidence of surgical site infection after cardiac surgery in our hospital, in spite of specific measures taken concerning some aspects of the surgical procedures, targeting a better control of the classically known major risk factors of infections, in routine procedures involving a sternotomy such as coronary artery bypass graft, valvuloplasty, aortic surgery, or combined procedures.

The first objective of this monocentric prospective cohort study, is to evaluate underestimated specific risk factors of surgical site infection, during the perioperative period, for patients undergoing cardiac surgery with sternotomy.

Secondly, to estimate the specific risk associated with each class or micro-organisms responsible, and their profile of resistance.

The outcomes concern the occurrence of a surgical site infection diagnosed by the surgeon in charge of the patient, one month and three months after surgery; it may concern the pre operative period, the procedure itself, or the early post operative period, characterized by a high density of cares, or even the late rehabilitation, after discharge of the surgical unit.

Secondary outcome evaluate the profile of agents identified regarding the susceptibility of the prophylaxis recommended to prevent wound infection; it may suggest that an adequate antibiotic prophylaxis is often insufficient to take into account the responsible agents, and that decolonisation is not always that helpful, in view of emerging cases of failure due to developing resistance.

Considering the low incidence of that type of complication, the investigators estimated that a period of two years might be necessary to include a sufficient number of patient, at least one thousand, in order to find a dozen of factors that might be significantly associated with an increased risk of surgical site infection.

The evaluation is permitted by the collaboration between the anesthesiologists, surgeons, intensivists, hygienists, all along the presence of the patient in the department, until discharge out of the hospital and after readmission eventually for infectious complication.


Condition or disease Intervention/treatment
Surgical Site Infection Procedure: Sternotomy for coronary artery bypass graft, valvuloplasty, aortic surgery or combined procedures, under extracorporeal circulation or not, in emergency or scheduled.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Study Start Date : March 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : November 2017



Primary Outcome Measures :
  1. Surgical Site infection [ Time Frame: 30 days after surgery ]

    Diagnostic made by the surgeon in charge of the patient, according to the criterias suggested by the CTINLS, on clinical or paraclinical elements.

    The occurrence during the first month may point out a potential interest of an intervention on a short term period (during and after surgery), concerning the cares administered inside the department of cardiothoracic surgery.


  2. Surgical Site Infection [ Time Frame: 90 days after surgery ]

    Diagnostic made by the surgeon in charge of the patient, according to the criterias suggested by the CTINLS, on clinical or paraclinical elements.

    The occurence of a delayed diagnosis may suggest a late infection, involving an intervention during and after the rehabiliation, outside the departement of cardiothoracic surgery.

    Some elements may concern the surgical period, but my be revealed several weeks after the discharge of the patient.



Secondary Outcome Measures :
  1. Bacterial Phenotype regarding the molecule administered as prophylaxis or decontamination preoperatively or during the procedure. [ Time Frame: 30 days after surgery ]

    The bacterial agent, causing the surgical site infection, susceptibility or resistance towards the antibiotic prophylaxis and the decontamination agents.

    Accurately, the susceptibility to mupirocin, cefuroxime, and vancomycin can vary and explain an early and agressive developement in the wound site.


  2. Bacterial Phenotype regarding the molecule administered as prophylaxis or decontamination preoperatively or during the procedure. [ Time Frame: 90 days after surgery ]

    The bacterial agent, causing the surgical site infection, susceptibility or resistance towards the antibiotic prophylaxis and the decontamination agents.

    Accurately, the susceptibility to mupirocin, cefuroxime, and vancomycin can vary and allow a low and delayed developement in the wound region.



Biospecimen Retention:   Samples Without DNA
Blood samples during and after intervention, for routine tests, and eventually dosing plasmatic concentration of the antibiotic administered for prophylaxis. Microbiological analyses concerning wound and blood samples.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Every patient undergoing a cardiac procedure with sternotomy, including coronary artery bypass, " , aortic surgery, or combined procedures, scheduled or on emergency, under extracorporeal circulation or not.
Criteria

Inclusion Criteria:

  • patient aged more than 18 yards old,
  • sternotomy for one of the following procedures : coronary artery bypass, valvuloplasty, aortic surgery, combination of the mentioned interventions.
  • without considering the degree on emergency and the presence of extra corporeal circulation.

Exclusion Criteria:

  • patient under age or 18years old.
  • patient not informed.
  • surgical revision in case of suspicion of infection, haemorragic complication, suspicion of myocardial infarction.
  • endocarditis indicating a valvuloplasty procedure.
  • patient who underwent orthopedic surgery with prothetic material, within the 12 months preceeding cardiac procedure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392936


Contacts
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Contact: Paul-Henri Wicky 0033-680-129-209 phwicky@outlook.fr
Contact: Benoît Barrucand, MD 0033-381-669-459 bbarrucand@chu-besancon.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Additional Information:

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Responsible Party: Paul-Henri WICKY, Anesthésiste-Réanimateur, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02392936    
Other Study ID Numbers: CHU Besancon
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015
Keywords provided by Paul-Henri WICKY, Centre Hospitalier Universitaire de Besancon:
according to the definition of the Comité Technique des Infections Nosocomiales et Liées aux Soins (2007)
Additional relevant MeSH terms:
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Infections
Surgical Wound Infection
Pathologic Processes
Wound Infection
Postoperative Complications