Comparison of Two Postoperative Infection Prevention Bundles in Colorectal Surgery. A Pragmatic Multicenter Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32,205
- 试验地点
- 2
- 主要终点
- Surgical site infection (SSI) incidence within 30 days of surgery according to the Centers for Disease Control and Prevention (CDC) criteria.
研究概览
简要总结
There is controversy about the maximum number of elements to be included in a surgical site infection (SSI) prevention bundle and the possibility of its implementation at a multi-center level.
This study analyzes SSI rates in colorectal surgery after the implementation of two preventive bundles.
The investigators hypothesized that the thorough introduction of a well-designed large bundle of best practice preventive measures would result in good adherence and greater reduction of SSI rates after colorectal surgery.
详细描述
To better understand the impact of adding new measures to an established bundle within a national surveillance program and to measure the effectiveness of each specific measures, the effect of a six-measure and a ten-measure bundle sequentially implemented on a large series of elective colorectal procedures from 2011 to 2022 was analized. In addition, it will be investigated whether taking advantage of a national surveillance programme for post-operative infections can facilitate the implementation of the packages.
Setting and patients. This is a pragmatic, cohort, multicentre study of a network of 65 public and private hospitals prospectively collecting data from elective colorectal surgery to minimise surgical site infection (SSI) rates and improve care. Prospective surveillance is conducted by each hospital's infection control team to ensure adequate data collection with a mandatory minimum follow-up of 30 days after surgery and electronic chart review checking readmissions, emergency department visits, microbiological and radiological data.
Patients undergoing elective colorectal surgery between January 2011 and December 2022 will be included. Cases with class 2 (clean-contaminated) and 3 (contaminated) wounds, according to the National Healthcare Safety Network classification, will be followed up. Patients with class 4 wounds (peritonitis) and previous ostomies are excluded.
Three sequential phases will be compared: a baseline period before package implementation (Baseline Group), from January 2011 to June 2016; a Bundle-1 period after implementation of a package of six measures (Bundle-1 Group), from July 2016 to June 2018; and a Bundle-2 period after implementation of a package of ten measures (Bundle-2 Group), from July 2018 to December 2022.
Definitions, study results and variables. The SSIs are defined according to the definitions of the Centers for Disease Control and Prevention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
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
- •Colon or rectal elective surgery.
排除标准
- •Peritonitis at the time of intervention ("dirty" surgery) Patients who underwent multiple procedures during the same surgery, for example resection of liver metastases Centers that performed less tan 10 surgical procedures annually Centers that have not been able to ensure prospective surveillance during hospitalization or effective monitoring of cases within 30 days of the intervention
结局指标
主要结局
Surgical site infection (SSI) incidence within 30 days of surgery according to the Centers for Disease Control and Prevention (CDC) criteria.
时间窗: 30 days
Overall surgical site infection (SSI) rate will be defined as any infection originating in surgical wounds or the organs/spaces opened or manipulated during an operative procedure. The incidence of SSI will be measured as events per 100 procedures included.
次要结局
- Organ/space surgical infection rate within 30 days of surgery according to the Centers for Disease Control and Prevention (CDC) criteria.(30 days)
- Hospital type-Surgical infection rate within 30 days of surgery according to the Centers for Disease Control and Prevention (CDC) criteria.(30 days)