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Clinical Trials/NCT04496635
NCT04496635RecruitingNot Applicable

Evaluation of the Application and Efficacy of Prevention Measures for Surgical Site Infection in Elective Colorectal Surgery.

Hospital de Granollers1 site in 1 country60,000 target enrollmentStarted: January 1, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
60,000
Locations
1
Primary Endpoint
Surgical site infection rate

Study Overview

Brief Summary

The Nosocomial Infection Surveillance Program in Catalonia (VINCat) monitors surgical site infection (SSI) in elective colorectal surgery since 2007 in 55 public and private acute care hospitals. These hospitals perform active and prospective standardized surveillance of elective colorectal resections. Post-discharge surveillance is mandatory at least up to 30 days after surgery. Hospitals are classified according to their size into three groups: >500 hospital beds; 200-500 beds; <200 beds.

Aim. To examine the effect on SSI rate of a specific preventative bundle in elective colorectal surgery.

Methods. Pragmatic study using VINCat prospective colorectal database from 2007 to 2018. In 2016, a bundle of six preventative measures was recommended to the VINCat hospitals.

To compare the results of SSI before (baseline phase, BP) and after the bundle implementation (implementation phase, IP) a logistic regression model has been established. The results will be shown as Odds Ratio (OR) and the corresponding confidence intervalsCI95. The significance level will be fixed at 5% (P < 0.05).

Detailed Description

Surveillance. The VINCat Program was developed in the 2007 as the Nosocomial Infection Surveillance system in Catalonia, covering a population of seven and a half million people. The system is similar to other international reference programs, such as the National Healthcare Safety Network (NHSN), and its described in detail on the VINCat website. Hospitals carry out active and prospective standardized surveillance, and are classified according to their number of beds into three groups: group 1 (500 beds); group 2 (200-500 beds); group 3 (200 beds). The staff performing surveillance had received training in the VINCat surveillance methodology to ensure the collection of homogeneous, accurate data.

Surveillance is continued at least for 30 days after the operation. All public and private participating hospitals report data voluntarily and receive feedback once a year.

Monitoring of colorectal surgery is performed prospectively and continued until a minimum of 100 interventions per year is reached in each hospital, although some centres include all their yearly cases. Hospitals with less than 10 interventions per year are excluded. Participating hospitals record the data on an Internet-based database.

Follow-up and post-discharge surveillance. Patients are followed up by trained infection control staff. Active mandatory post-discharge surveillance is performed at least to day 30 post surgery by a multimodal approach including electronic review of clinical records (primary and secondary care), checking readmissions, checking emergency visits, and reviewing microbiological and radiological data.

Development of the colorectal surgical site infection program. In 2015, a multidisciplinary team of nurses and medical specialists from the VINCat Program, and surgeons belonging to the Catalan Society of Surgery was set up to formulate a specific bundle of SSI preventative measures for colorectal surgery. The literature for optimal care during the preoperative, intraoperative and postoperative phases was reviewed, including evidence on oral antibiotic prophylaxis and mechanical bowel preparation. Practices were chosen either by their high levels of scientific evidence or by being considered, by consensus, reasonable, associated with minimal risk, and potentially beneficial.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Colon or rectal elective surgery.

Exclusion Criteria

  • •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

Arms & Interventions

Baseline phase

No Intervention

Patients included in the VINCat program, and operated on colorectal surgery between 2007 and 2015 in Catalonia

Implementation phase

Experimental

Patients included in the VINCat program, and operated on colorectal surgery between 2016 and 2018 in Catalonia

Intervention: Implementation of a bundle of care (Other)

Outcomes

Primary Outcomes

Surgical site infection rate

Time Frame: 30 days

Overall surgical infection rate

Secondary Outcomes

  • Hospital type-Surgical infection rate(30 days)
  • Analysis (logistic regression model) of the efficacy of each preventive measure(30 days)
  • Organ/space surgical infection rate(30 days)

Investigators

Sponsor
Hospital de Granollers
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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