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

NCT02392936 | Unknown

• 1 other identifier: CHU Besancon
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Surgical Site Infection

Keywords

according to the definition of the Comité Technique des Infections Nosocomiales et Liées aux Soins (2007)

Outcome Measures

Primary Outcomes (2)

• Surgical Site infection

  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.

  30 days after surgery

• Surgical Site Infection

  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.

  90 days after surgery

Secondary Outcomes (2)

• Bacterial Phenotype regarding the molecule administered as prophylaxis or decontamination preoperatively or during the procedure.

  30 days after surgery

• Bacterial Phenotype regarding the molecule administered as prophylaxis or decontamination preoperatively or during the procedure.

  90 days after surgery

Interventions

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

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

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.

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Sternotomy; Coronary Artery Bypass; Nuclear Receptor Subfamily 4, Group A, Member 2; Appointments and Schedules

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thoracic Surgical Procedures; Surgical Procedures, Operative; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Vascular Grafting; Vascular Surgical Procedures; Orphan Nuclear Receptors; DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cytoplasmic and Nuclear; Organization and Administration; Health Services Administration

Central Study Contacts

Paul-Henri Wicky

CONTACT

0033-680-129-209; phwicky@outlook.fr

Benoît Barrucand, MD

CONTACT

0033-381-669-459; bbarrucand@chu-besancon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthésiste-Réanimateur

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 19, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 19, 2015

Record last verified: 2015-03