Reduction of Surgical Site Infections in Elective Colorectal Surgery After the Implementation of a Bundle of Preventative Measures. Multicenter Study of the Nococomial Infection Surveillance Program in Catalonia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12,000
- 试验地点
- 1
- 主要终点
- Surgical site infection rate
研究概览
简要总结
Background. The Nosocomial Infection Surveillance Program in Catalonia (VINCat) monitors SSI in elective colorectal surgery since 2007 in 56 hospitals (7.5 million population). These hospitals perform active and prospective standardized surveillance of elective colorectal resections. Post-discharge surveillance is mandatory up to 30 days after surgery. Between 2007 and 2015, the SSI rate did not change significantly, with a cumulated incidence of 5,491 SSI in a total of 29,006 interventions (19%). In 2015, a working group of VINCat specialists and surgeons from the Catalan Society of Surgery was set up to formulate a specific bundle of SSI preventative measures for colorectal surgery.
Aim. To analyse the effect of a specific bundle for SSI prevention in elective colorectal surgery.
Methods. In 2016, a bundle of six preventative measures was recommended to the VINCat hospitals. Bundle measures were: systemic and oral antibiotic prophylaxis, mechanical bowel preparation (MBP), laparoscopic surgery, maintenance of normothermia, and the use of a double-ring wound retractor. The results of SSI before and after the implementation of the bundle are compared. The results are analysed using the chi-square test (statistical significance p <0.05).
详细描述
Surgical location infection (ILQ) is the most frequent complication of surgery and an important source of clinical and economic problems for health systems. The reduction of its incidence is important because of its impact on patient comfort and the health resources used. The ILQ includes the categories of: superficial incisional (IIS, affects skin and subcutaneous tissue); deep incisional (IIP, affects deep soft tissues), and organ-space or organ-cavitary (IOE, affects any anatomical structure other than the incision manipulated during the intervention). Surgical procedures are distributed in the categories of clean, clean-contaminated, contaminated and dirty or infected surgery depending on your risk of ILQ.
Elective colorectal surgery belongs to the clean-contaminated surgery category, it is one of the most frequent surgical procedures in Western society and the one with the highest rate of postoperative infection. The ILQ after colorectal procedures represents a measurable indicator of the quality of a health system. Endogenous factors of the patient and exogenous factors related to the surgical procedure are involved in the development of the ILQ.
Despite the introduction of laparoscopy and the standardization of perioperative measures of prophylaxis, the clean-contaminated nature of these procedures, the increase in comorbidities and age of patients and the increase in the complexity of surgical procedures do not improve the Postoperative ILQ rates. It is necessary to investigate the usefulness of complementary prophylactic measures that allow lowering the level of wound contamination and reducing the rate of ILQ.
The grouping of ILQ prevention measures into bundles or packages of measures with a high level of evidence is a strategy that has proven effective in various types of surgical procedures. The overall effectiveness of a package of measures depends on the degree of individual effectiveness of each of the measures included in the bundle.
The Nosocomial Infection Surveillance Program in Catalonia (VINCat) has been monitoring ILQ rates in elective colorectal surgery since 2007 in 55 hospitals. These hospitals perform active and prospective standardized surveillance of elective colorectal resections. Post-discharge surveillance is mandatory up to 30 days after surgery. Between 2007 and 2015, the rate of ILQ did not change significantly, with a cumulative incidence of 5,491 ILQ in a total of 29,006 interventions (19%). Given the persistence of these infection rates, in 2015, an interdisciplinary working group was formed that included infection control nurses, infectious disease specialists, anesthetists and surgeons of the Catalan Society of Surgery. Its objective was to design a specific package of ILQ preventive measures for elective colorectal surgery that could affect the incisional infection and organ / space.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective colorectal resection
排除标准
- •Emergency surgery - Infection present at operation
结局指标
主要结局
Surgical site infection rate
时间窗: 30 days
Rate of Surgical site infection according to the definitions of the CDC-NHSN (Centers for Disease Control and Prevention-National Healthcare Safety Network)
次要结局
未报告次要终点
研究者
Josep M Badia
Director of surgical infection department
Hospital de Granollers
