Understanding the Drivers of Surgical Site Infection: Investigating and Modeling the Swissnoso Surveillance Data

NCT03883009 | Completed

• 1 other identifier: 32003B_179500
• Study Type: observational
• Target: 318,000
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical site infection (SSI) is the most common healthcare-associated infection, multifactorial in nature, and a typical preventable harm. Many healthcare systems require hospitals to determine the corresponding infection rates as a quality indicator and often stipulate public reporting of these data. Several agencies, among them the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC), have issued evidence-based prevention guidelines. Despite efforts in implementing best practice, SSI continue to be a relevant complication of modern surgical procedures and generate enormous costs for the healthcare system. Moreover, prevention guidelines acknowledge that the evidence backing their recommendations is low to moderate in most cases, which is partly due to the complexity of SSI pathogenesis. Swissnoso, the Swiss expert group for infection prevention and hospital epidemiology, oversees the nationwide collection of data on select procedures and the associated SSI. Since the inception of this dedicated surveillance in 2009, more than 300'000 procedures have been included and the corresponding patients were followed to ascertain SSIs. Although primarily conceived as a national surveillance system and then used for public reporting starting in 2014, Swissnoso is a prime data source for better understanding the epidemiology of SSI. Here, the investigators seek to raise the quality of evidence behind future prevention guidelines. For this purpose, the investigators will move from a risk factor analysis for SSI (of which a substantial part occurs after patient discharge from the hospital, rendering surveillance difficult) to the collection of additional data (in order to better characterize certain determinants of SSI and their recognition) and, finally, to a mathematical model (which will simulate the probability of developing SSI so the investigators can test what may modulate this risk).

Conditions

Surgical Site Infection

Keywords

Epidemiology; Modeling; Risk factors; Surgical site infections

Outcome Measures

Primary Outcomes (1)

• Surgical site infection rate

  Number of surgical site infection per number of corresponding surgery

  During 30 days after surgery (or 12 months after surgery with implants)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Swissnoso SSI Surveillance: Nationwide surveillance system with 172 participating hospitals collecting data on patients who undergo select surgeries as defined by Swissnoso. Since 2009, information on 318'000 surgical procedures has been captured (database extract February 2017).

You may qualify if:

• All cases included in the Swissnoso SSI Surveillance system are eligible for the analyses.

You may not qualify if:

• If a patient opts to withdraw consent to participating in the Swissnoso SSI Surveillance, his/her data is removed from the surveillance dataset.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Swiss Patient Safety Foundation: collaborator
• Lucerne University of Applied Sciences and Arts: collaborator
• University of Bern: collaborator
• Swissnoso National Center for Infection Control: collaborator
• Central Institute of Valais Hospitals: collaborator
• University Hospital, Basel, Switzerland: collaborator
• Swiss National Science Foundation: collaborator

Study Sites (1)

University Hospital Bern

Bern, Switzerland

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonas Marschall, Prof.Dr.med.

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 20, 2019
• Study Start: August 1, 2018
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: January 27, 2023

Record last verified: 2023-01

Locations

CH (1)