Surgical Site InfectionWATUSSINCT03883009
Understanding the Drivers of Surgical Site Infection: Investigating and Modeling the Swissnoso Surveillance Data
An observational study of Surgical Site Infection, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Site Infection
- How many people
- 318,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2018to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- All cases included in the Swissnoso SSI Surveillance system are eligible for the analyses.
Who cannot join
- If a patient opts to withdraw consent to participating in the Swissnoso SSI Surveillance, his/her data is removed from the surveillance dataset.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
Aim 1: Descriptive epidemiology and risk factors for (post-discharge) SSI: using the Swissnoso SSI Surveillance data, the investigators will determine patient and institution level risk factors for SSI in Switzerland (with a focus on those occurring post-discharge), explore protective factors (such as antimicrobial prophylaxis and its timing), and describe the epidemiology of SSI in terms of time of occurrence, microbiology, severity, patient outcome, and variation by procedure type, case-mix, and hospital size.
Aim 2: Determinants of SSI: The investigators will investigate determinants of SSI in the following three areas:
- The surveillance system itself and how the thoroughness of the surveillance process correlates with reported SSI rates; B) The operating room ventilation system and how its parameters correlate with SSI rates; and C) A healthcare institution's perceived culture of safety and how it correlates with infection rates.
To do so, the investigators will enhance and complement the Swissnoso data with new information at the institution level.
Aim 3: A mathematical model of surgical site infection: the investigators will construct a mathematical model that simulates SSI pathogenesis based on data from Swissnoso and other sources, and assesses the impact of different preventive measures. Interventions will be ranked according to the simulated reduction of SSI rates in Switzerland.
- Conditions
- Surgical Site Infection
- Keywords
- Epidemiology, Modeling, Risk factors, Surgical site infections
- Medical subject headings
- Surgical Wound Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection rate
Number of surgical site infection per number of corresponding surgery
Measured: During 30 days after surgery (or 12 months after surgery with implants)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start1 Aug 2018
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 318,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Patient Safety Foundation, Lucerne University of Applied Sciences and Arts, University of Bern, Swissnoso National Center for Infection Control, Central Institute of Valais Hospitals, University Hospital, Basel, Switzerland, Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Jonas Marschall, Prof.Dr.med., Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883009
- Sponsor's protocol ID
- 32003B_179500
- Acronym
- WATUSSI
- Status last verified
- Jan 2023
- First submitted
- 18 Mar 2019
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Drivers of Surgical Site Infection: Investigating and Modeling the Swissnoso Surveillance Data
- ClinicalTrials.gov ID
- NCT03883009
- Acronym / sponsor ID
- WATUSSI / 32003B_179500
- Conditions
- Surgical Site Infection
- Keywords
- Epidemiology, Modeling, Risk factors, Surgical site infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318,000 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Swiss Patient Safety Foundation, Lucerne University of Applied Sciences and Arts, University of Bern, Swissnoso National Center for Infection Control, Central Institute of Valais Hospitals, University Hospital, Basel, Switzerland, Swiss National Science Foundation
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Aim 1: Descriptive epidemiology and risk factors for (post-discharge) SSI: using the Swissnoso SSI Surveillance data, the investigators will determine patient and institution level risk factors for SSI in Switzerland (with a focus on those occurring post-discharge), explore protective factors (such as antimicrobial prophylaxis and its timing), and describe the epidemiology of SSI in terms of time of occurrence, microbiology, severity, patient outcome, and variation by procedure type, case-mix, and hospital size.
Aim 2: Determinants of SSI: The investigators will investigate determinants of SSI in the following three areas:
- The surveillance system itself and how the thoroughness of the surveillance process correlates with reported SSI rates; B) The operating room ventilation system and how its parameters correlate with SSI rates; and C) A healthcare institution's perceived culture of safety and how it correlates with infection rates.
To do so, the investigators will enhance and complement the Swissnoso data with new information at the institution level.
Aim 3: A mathematical model of surgical site infection: the investigators will construct a mathematical model that simulates SSI pathogenesis based on data from Swissnoso and other sources, and assesses the impact of different preventive measures. Interventions will be ranked according to the simulated reduction of SSI rates in Switzerland.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- All cases included in the Swissnoso SSI Surveillance system are eligible for the analyses.
Key exclusion criteria (1 listed)
- If a patient opts to withdraw consent to participating in the Swissnoso SSI Surveillance, his/her data is removed from the surveillance dataset.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical site infection rate
Time frame: During 30 days after surgery (or 12 months after surgery with implants)
Number of surgical site infection per number of corresponding surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas Marschall, Prof.Dr.med. principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection rate (time frame: During 30 days after surgery (or 12 months after surgery with implants)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.