Staphylococcus AureusSALTNCT03353532
Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe
An observational study of Staphylococcus Aureus and Wound Infection, Surgical, run by University of Cologne at 14 sites in 5 countries.
Trial summary
This is a retrospective multinational, multicenter cohort study with a nested case-control. The study includes all surgical procedures performed at a participating site to prevent bias. Data will be assessed in two populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus, Wound Infection, Surgical, Epidemiology
- How many people
- 178,902 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 1 Aug 2017to 31 Jan 2021
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients with SSI after any surgical procedure
Who may be able to join
- Age ≥18 years at the time of surgery
Who cannot join
- Cases with missing data defined as "missing completely at random" (MCAR)
- Infection at the time of surgery
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
Spain5 sites
Hospital Clínic Barcelona
Barcelona
Institut Hospital del Mar d'Investigacions Mèdiques
Barcelona
Hospital General Universitario Gregorio Marañón e Instituto de Investigación Sanitaria Gregorio Marañón
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital Universitari i Politècnic La Fe
Valencia
Germany4 sites
University Hospital Bonn
Bonn
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50937
Jena University Hospital
Jena
Hospital of the University of Munich
Munich
France3 sites
Centre Hospitalier Départemental Vendee
La Roche-sur-Yon
Centre Hospitalier et Universitaire de Limoges
Limoges
Centre Hospitalier Régional et Universitaire de Tours
Tours
Italy1 site
University of Udine and Azienda Sanitaria Universitaria Integrata
Udine
United Kingdom1 site
Manchester University NHS Foundation Trust (MFT)
Manchester
About this study
This is a retrospective multinational, multicenter cohort study with a nested case-control. The study includes all surgical procedures performed at a participating site to prevent bias.
Data will be assessed in two populations.
Read more
Cohort population: Export of electronic file data on demographics, surgical procedure ICPM code, duration of procedure, American Society of Anesthesiologists (ASA) score, body mass index, comorbidity ICD codes, and wound class of all patients undergoing surgery.
Nested case-control population: For patients establishing S. aureus SSI and 1:1 matched controls from the same center further data will be captured: Length of hospitalization, length of ICU stay and reason as well as attribution to SSI, survival at 30 and at 90 days, antibiotic treatments including duration, functional status at admission and at final discharge; necessity for surgical revision, and death attributed to SSI.
If readmission is necessary, reason and attribution to SSI, length of hospitalization and length of ICU stay as well as all antibiotic treatments and their duration will be recorded.
The cases causative pathogens including resistance patterns and type of SSI according to CDC criteria will be captured.
Matching criteria comprise the following:
- Type of procedure
- Age
- ASA score
- BMI
- Duration of procedure (as percentile for this procedure)
- Diabetes
- Sex
- Medical subject headings
- Staphylococcal Infections, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Adult patients with SSI after any surgical procedure. | |
| Case-Control | Cases: Patients establishing S. aureus SSI Controls: Patients from the same center who did not undergo S. aureus SSI, matched by the following criteria * Type of procedure * Age * ASA score * BMI * Duration of procedure (as percentile for this procedure) * Diabetes * Sex |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine overall incidence of Staphylococcus aureus surgical site infections in Europe
Surgical site infections will be determined within the cohort of all patients that underwent surgery within 1 year at all participating sites.
Measured: 30 days from surgical procedure
To determine procedure specific incidence of Staphylococcus aureus surgical site infections in Europe
Surgical site infections will be determined within the cohort of all patients that underwent surgery within 1 year at all participating sites. A subgroup Analysis will reveal procedure specific incidence.
Measured: 30 days from surgical procedure
Secondary outcomes (4)
To determine the overall outcomes of Staphylococcus aureus surgical site infections in Europe
The Outcome will be assessed within the case-control part and achieved by comparison of Overall Outcome of cases and controls
Measured: 30 days from surgical procedure
To determine the procedure specific outcomes of Staphylococcus aureus surgical site infections in Europe
The Outcome will be assessed within the case-control part and achieved by comparison of procedure specific Outcome of cases and controls
Measured: 30 days from surgical procedure
To determine the overall economic burden of Staphylococcus aureus surgical site infections in Europe
The economic burden will be assessed within the case-control part and achieved by comparison of Overall economic burden (i.e. ICU Treatment, hemodialysis and mechanical Ventilation) of cases and controls
Measured: 30 days from surgical procedure
To determine the procedure specific economic burden of Staphylococcus aureus surgical site infections in Europe
The economic burden will be assessed within the case-control part and achieved by comparison of procedure specific economic burden (i.e. ICU Treatment, hemodialysis and mechanical Ventilation) of cases and controls
Measured: 30 days from surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start1 Aug 2017
- Primary completion1 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Staphylococcus AureusStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 178,902 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Oliver Cornely, MD, University of Cologne
- Investigators
- Oliver A Cornely, MD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353532
- Sponsor's protocol ID
- SALT
- Acronym
- SALT
- Status last verified
- May 2021
- First submitted
- 20 Nov 2017
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mellinghoff SC, Bruns C, Albertsmeier M, Ankert J, Bernard L, Budin S, Bataille C, Classen AY, Cornely FB, Couve-Deacon E, Fernandez Ferrer M, Fortun J, Galar A, Grill E, Guimard T, Hampl JA, Wingen-Heimann S, Horcajada JP, Kohler F, Koll C, Mollar J, Munoz P, Pletz MW, Rutz J, Salmanton-Garcia J, Seifert H, Serracino-Inglott F, Soriano A, Stemler J, Vehreschild JJ, Vilz TO, Naendrup JH, Cornely OA, Liss BJ. Staphylococcus aureus surgical site infection rates in 5 European countries. Antimicrob Resist Infect Control. 2023 Sep 19;12(1):104. doi: 10.1186/s13756-023-01309-w.
PubMed 37726843Mellinghoff SC, Bruns C, Al-Monajjed R, Cornely FB, Grosheva M, Hampl JA, Jakob C, Koehler FC, Lechmann M, Maged B, Otto-Lambertz C, Rongisch R, Rutz J, Salmanton-Garcia J, Schlachtenberger G, Stemler J, Vehreschild J, Wulfing S, Cornely OA, Liss BJ. Harmonized procedure coding system for surgical procedures and analysis of surgical site infections (SSI) of five European countries. BMC Med Res Methodol. 2022 Aug 12;22(1):225. doi: 10.1186/s12874-022-01702-w.
PubMed 35962320Mellinghoff SC, Vehreschild JJ, Liss BJ, Cornely OA. Epidemiology of Surgical Site Infections With Staphylococcus aureus in Europe: Protocol for a Retrospective, Multicenter Study. JMIR Res Protoc. 2018 Mar 12;7(3):e63. doi: 10.2196/resprot.8177.
PubMed 29530837
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe
- ClinicalTrials.gov ID
- NCT03353532
- Acronym / sponsor ID
- SALT / SALT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178,902 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 27 Nov 2017 (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.
This is a retrospective multinational, multicenter cohort study with a nested case-control. The study includes all surgical procedures performed at a participating site to prevent bias.
Data will be assessed in two populations.
Cohort population: Export of electronic file data on demographics, surgical procedure ICPM code, duration of procedure, American Society of Anesthesiologists (ASA) score, body mass index, comorbidity ICD codes, and wound class of all patients undergoing surgery.
Nested case-control population: For patients establishing S. aureus SSI and 1:1 matched controls from the same center further data will be captured: Length of hospitalization, length of ICU stay and reason as well as attribution to SSI, survival at 30 and at 90 days, antibiotic treatments including duration, functional status at admission and at final discharge; necessity for surgical revision, and death attributed to SSI.
If readmission is necessary, reason and attribution to SSI, length of hospitalization and length of ICU stay as well as all antibiotic treatments and their duration will be recorded.
The cases causative pathogens including resistance patterns and type of SSI according to CDC criteria will be captured.
Matching criteria comprise the following:
- Type of procedure
- Age
- ASA score
- BMI
- Duration of procedure (as percentile for this procedure)
- Diabetes
- Sex
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | –Adult patients with SSI after any surgical procedure. |
| Case-Control | – | –Cases: Patients establishing S. aureus SSI Controls: Patients from the same center who did not undergo S. aureus SSI, matched by the following criteria * Type of procedure * Age * ASA score * BMI * Duration of procedure (as percentile for this procedure) * Diabetes * Sex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with SSI after any surgical procedure
Key inclusion criteria (1 listed)
- Age ≥18 years at the time of surgery
Key exclusion criteria (2 listed)
- Cases with missing data defined as "missing completely at random" (MCAR)
- Infection at the time of surgery
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
To determine overall incidence of Staphylococcus aureus surgical site infections in Europe
Time frame: 30 days from surgical procedure
Surgical site infections will be determined within the cohort of all patients that underwent surgery within 1 year at all participating sites.
To determine procedure specific incidence of Staphylococcus aureus surgical site infections in Europe
Time frame: 30 days from surgical procedure
Surgical site infections will be determined within the cohort of all patients that underwent surgery within 1 year at all participating sites. A subgroup Analysis will reveal procedure specific incidence.
4 secondary outcomes
To determine the overall outcomes of Staphylococcus aureus surgical site infections in Europe
Time frame: 30 days from surgical procedure
To determine the procedure specific outcomes of Staphylococcus aureus surgical site infections in Europe
Time frame: 30 days from surgical procedure
To determine the overall economic burden of Staphylococcus aureus surgical site infections in Europe
Time frame: 30 days from surgical procedure
To determine the procedure specific economic burden of Staphylococcus aureus surgical site infections in Europe
Time frame: 30 days from surgical procedure
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 24 May 2021.
- Derived from this study: PubMed 37726843Mellinghoff SC, Bruns C, Albertsmeier M, Ankert J, Bernard L, Budin S, Bataille C, Classen AY, Cornely FB, Couve-Deacon E, Fernandez Ferrer M, Fortun J, Galar A, Grill E, Guimard T, Hampl JA, Wingen-Heimann S, Horcajada JP, Kohler F, Koll C, Mollar J, Munoz P, Pletz MW, Rutz J, Salmanton-Garcia J, Seifert H, Serracino-Inglott F, Soriano A, Stemler J, Vehreschild JJ, Vilz TO, Naendrup JH, Cornely OA, Liss BJ. Staphylococcus aureus surgical site infection rates in 5 European countries. Antimicrob Resist Infect Control. 2023 Sep 19;12(1):104. doi: 10.1186/s13756-023-01309-w.
- Derived from this study: PubMed 35962320Mellinghoff SC, Bruns C, Al-Monajjed R, Cornely FB, Grosheva M, Hampl JA, Jakob C, Koehler FC, Lechmann M, Maged B, Otto-Lambertz C, Rongisch R, Rutz J, Salmanton-Garcia J, Schlachtenberger G, Stemler J, Vehreschild J, Wulfing S, Cornely OA, Liss BJ. Harmonized procedure coding system for surgical procedures and analysis of surgical site infections (SSI) of five European countries. BMC Med Res Methodol. 2022 Aug 12;22(1):225. doi: 10.1186/s12874-022-01702-w.
- Derived from this study: PubMed 29530837Mellinghoff SC, Vehreschild JJ, Liss BJ, Cornely OA. Epidemiology of Surgical Site Infections With Staphylococcus aureus in Europe: Protocol for a Retrospective, Multicenter Study. JMIR Res Protoc. 2018 Mar 12;7(3):e63. doi: 10.2196/resprot.8177.
- Individual participant dataSharing planned: Undecided
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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.
Oliver A Cornely, MD principal investigator
University of Cologne
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcus Aureus and Wound Infection, Surgical, run by University of Cologne at 14 sites in 5 countries.
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 2 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 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain, Germany, France, Italy, United Kingdom. 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?
To determine overall incidence of Staphylococcus aureus surgical site infections in Europe (time frame: 30 days from surgical procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03353532, which also lists 3 linked publications.
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 24 May 2021.