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Surveillance and Implementation of a Bundle of Care to Reduce Surgical Site Infection in Colorectal Surgery (CCR-VINCat)

NCT04496635 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60000

Last updated 2023-08-22

No results posted yet for this study

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).

Conditions

  • Colon Rectal Cancer
  • Surgical Site Infection

Interventions

OTHER

Implementation of a bundle of care

Sponsors & Collaborators

  • Hospital de Granollers

    lead OTHER

Principal Investigators

  • Josep M Badia-Perez, MD, PhD · Fundació Hospital General de Granollers

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-01
Primary Completion
2025-11-30
Completion
2025-12-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04496635 on ClinicalTrials.gov