Evaluation of Peri-operative Risk Factors for Surgery Site Infection in Cardiac Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 主要终点
- Surgical Site infection
研究概览
简要总结
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.
详细描述
Surgical site infection following cardiac surgery is source of a significant morbidity and mortality. It may occur in patients who present preexisting fragilizing underlying conditions, and who suffer a major surgical traumatism, considering the sternotomy, the presence of an eventual extracorporeal circulation, the bleeding risk associated to the procedure, hypothermia, etc.
Many risk factors have already been studied, and might be targeted by prevented measures.
Some of them concern the pre-operative period, related to the patient's underlying conditions, the disinfection and eventual decolonisation of the patients; some concern the procedure intrinsically, according to the surgical technique preferred; an important role may be accorded to the post-operative period, during which a high density of care might be responsible of an eventual contamination, recolonisation, or fragilisation of the patients, thus making them more susceptible to infection.
Despite the control of the modifiable risk factors and the application of preventive measures, we are facing a progressive increasing in surgical site infection since a few months.
We aim to prospectively and exhaustively evaluate all the risk factors that can play a role before, during or after the surgical period, in the routine procedures involving a sternotomy, including coronary artery bypass graft, valvuloplasty (except for endocarditis), thoracic aortic surgery, and combined procedures, without considering the degree of emergency, the presence of an extracorporeal membrane, in every major adult admitted in the department of cardiothoracic surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Surgical Site infection
时间窗: 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.
Surgical Site Infection
时间窗: 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.
次要结局
- Bacterial Phenotype regarding the molecule administered as prophylaxis or decontamination preoperatively or during the procedure.(90 days after surgery)
研究者
Paul-Henri WICKY
Anesthésiste-Réanimateur
Centre Hospitalier Universitaire de Besancon