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

NCT06244836 | Completed

• 1 other identifier: CCR-VINCat2
• Study Type: interventional
• Target: 32,205
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colon Cancer; Rectal Cancer; Surgical Site Infection

Keywords

Surveillance; Surgical site infection; Colorectal surgery; Prevention; Preventive measures; Bundle of care

Outcome Measures

Primary Outcomes (1)

• Surgical site infection (SSI) incidence within 30 days of surgery according to the Centers for Disease Control and Prevention (CDC) criteria.

  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 Outcomes (2)

• 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

Study Arms (3)

Baseline group

NO INTERVENTION

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

Implementation of a six-measures Bundle-1 (Bundle 1 Group)

EXPERIMENTAL

Bundle-1 period after the implementation of a six-measure bundle, from July 2016 to June 2018

Other: Implementation of a bundle of care

Implementation of a ten-measures Bundle-2 (Bundle 2 Group)

EXPERIMENTAL

Bundle-2 period after the implementation of a ten-measure bundle, from July 2018 to December 2022

Other: Implementation of a bundle of care

Interventions

Implementation of a bundle of care OTHER

Implementation of a six-measures Bundle-1 (Bundle 1 Group); Implementation of a ten-measures Bundle-2 (Bundle 2 Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Colon or rectal elective surgery.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Granollers: lead

Study Sites (1)

Hospital General de Granollers

Granollers, Barcelona, 08402, Spain

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Josep M Badia, MD, PhD

  Hospital General de Granollers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study compare three phases: a baseline period before bundle implementation (Baseline Group), from January 2011 to June 2016; a Bundle-1 period after the implementation of a six-measure bundle (Bundle-1 Group), from July 2016 to June 2018; and a Bundle-2 period after the implementation of a ten-measure bundle (Bundle-2 Group), from July 2018 to December 2022

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 6, 2024
• Study Start: January 1, 2011
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)