Comparison of Two Bundles of Care to Reduce Surgical Site Infection in Colorectal Surgery (CCR-VINCat 2) (CCR-VINCat2)

January 29, 2024 updated by: Hospital de Granollers

Comparison of Two Postoperative Infection Prevention Bundles in Colorectal Surgery. A Pragmatic Multicenter Cohort Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

The primary objective will be to analyse the effect of the implementation of the package on the prevention of SSIs and their subtypes and to assess compliance and effectiveness of individual measures. Secondary outcomes will be length of stay, mortality and micro-organisms causing SSIs.

Intervention. In the Reference Group, some measures such as intravenous antibiotic prophylaxis and the use of laparoscopy were included as standard clinical practice. In Bundle-1, six well-documented colorectal-specific measures were introduced: intravenous antibiotic prophylaxis, laparoscopy, oral antibiotic prophylaxis, mechanical bowel preparation, normothermia and double-ring plastic wound retractor. In Bundle-2, four additional general measures were incorporated in addition to the above: adequate depilation, skin antisepsis with 2% chlorhexidine gluconate in alcohol, perioperative glucose control and instrument change before wound closure.

Study Type

Interventional

Enrollment (Actual)

32205

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Granollers, Barcelona, Spain, 08402
        • Hospital General de Granollers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Baseline group
Patients included in the Catalan Nosocomial Infection surveillance Program (VINCat) program, and operated on colorectal surgery before bundle implementation, from January 2011 to June 2016
Experimental: Implementation of a six-measures Bundle-1 (Bundle 1 Group)
Bundle-1 period after the implementation of a six-measure bundle, from July 2016 to June 2018
Other: Implementation of a bundle of care
Experimental: Implementation of a ten-measures Bundle-2 (Bundle 2 Group)
Bundle-2 period after the implementation of a ten-measure bundle, from July 2018 to December 2022
Other: Implementation of a bundle of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical site infection (SSI) incidence within 30 days of surgery according to the Centers for Disease Control and Prevention (CDC) criteria.
Time Frame: 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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Organ/space surgical infection rate within 30 days of surgery according to the Centers for Disease Control and Prevention (CDC) criteria.
Time Frame: 30 days
Specific organ/space surgical infection (O/S-SSI) rate. O/S-SSI is the infection that involves any part of the anatomy in organs and spaces other than the incision, which is opened or manipulated during operation. he incidence of O/S-SSI will be measured as events per 100 procedures included.
30 days
Hospital type-Surgical infection rate within 30 days of surgery according to the Centers for Disease Control and Prevention (CDC) criteria.
Time Frame: 30 days
Comparison of SSIs rates among the three hospitals groups, according to their size. The hospitals are classified into three groups according to their complexity and number of hospital beds: >500 beds; 200-500 beds; ≤200 beds.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Granollers

Investigators

  • Principal Investigator: Josep M Badia, MD, PhD, Hospital General de Granollers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR-VINCat2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be shared if requested

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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