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

NCT02392936 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2015-03-19

No results posted yet for this study

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.

Conditions

  • Surgical Site Infection

Interventions

PROCEDURE

Sternotomy for coronary artery bypass graft, valvuloplasty, aortic surgery or combined procedures, under extracorporeal circulation or not, in emergency or scheduled.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-03-31
Completion
2017-11-30

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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 NCT02392936 on ClinicalTrials.gov