Staphylococcus Aureus, Surgical Wound Infection
Conditions
Keywords
Epidemiology, Staphylococcus aureus, Prospective observational, Surgical site or wound infection
Brief summary
ASPIRE-SSI is a prospective, observational, multicentre cohort study among adult surgical patients, which aims to determine the incidence of healthcare-associated S. aureus infections, particularly S. aureus surgical site infections (SSIs), across Europe and to assess the most important risk factors for this type of infection.
Detailed description
The primary objective of ASPIRE-SSI is to determine the incidence of S. aureus infections, particularly S. aureus SSIs, in various adult surgical patient populations, and to identify the patient-related, pathogen-related, and contextual risk factors for the development of S. aureus SSI. Using this information, a SSI prediction tool will be derived for future clinical trials and public health interventions aimed at SSI prevention. Furthermore, immunologic features protective against S. aureus SSI will also be assessed. The knowledge obtained by this study will enable identification of the surgical patients most at risk of developing S. aureus infections, particularly S. aureus SSI, and who would probably benefit most from new interventions given prophylactically and specifically to prevent S. aureus infections.
Interventions
None listed
Sponsors
MedImmune LLC
UMC Utrecht
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is 18 years of age or older. * The subject is undergoing 1 of the protocol-defined surgical procedures. The surgical procedure is planned or unplanned. * The subject has been screened for S. aureus colonization from three body regions: nose, throat, and perineum within 30 days prior to surgery, and based on the preoperative S. aureus colonization status of the subject, the subject qualifies for enrolment in the study cohort. * Written informed consent has been obtained prior to enrollment in the study cohort.
Exclusion criteria
* Parallel participation in any experimental study of an anti-Staphylococcus preventive intervention. * An active diagnosis of a SSI as the reason for surgery. * Not able to comply with study procedures and follow-up based on Investigator judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of S. aureus SSI | Up to 90 days following surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of all-cause SSI, by etiologic agent | Up to 90 days following surgery | — |
| Incidence of S. aureus SSI stratified by location of preoperative S. aureus colonization | Up to 90 days following surgery | — |
| Incidence of post-surgical all-cause mortality | Up to 90 days following surgery | — |
| Semi-quantification of the bacterial load of colonizing S. aureus | At the time of preoperative screening for S. aureus colonization (within 30 days prior to surgery) | — |
| Characterization of S. aureus isolates involved in colonization | At the time of preoperative screening for S. aureus colonization (within 30 days prior to surgery) | Clonal type, gene sequence, and expression of certain virulence factors of S. aureus isolates |
| Serum antibody levels against S. aureus virulence factors. | Within 30 days prior to surgery (for the preoperative sample) and 2-6 weeks following the SSI episode (for the post-SSI sample) | — |
| Characterization of S. aureus isolates involved in infections | Up to 90 days following surgery | Clonal type, gene sequence, and expression of certain virulence factors of S. aureus isolates |
| Incidence of serious S. aureus SSI (deep and organ/space S. aureus SSI) | Up to 90 days following surgery | — |
| Incidence of S. aureus bloodstream infection | Up to 90 days following surgery | — |
| Incidence of other post-surgical S. aureus infection | Up to 90 days following surgery | — |
| Incidence of S. aureus SSI stratified by antibiotic susceptibility | Up to 90 days following surgery | — |
| Prevalence of preoperative S. aureus colonization in nose, throat and perineal region. | No more than 30 days prior to surgery | — |
Other
| Measure | Time frame |
|---|---|
| Incidence of S. aureus SSI, stratified by type of surgery | Up to 90 days following surgery |
| Incidence of S. aureus SSI, stratified by wound classification | Up to 90 days following surgery |
| Incidence of S. aureus SSI, stratified by urgency of surgery | Up to 90 days following surgery |
| Incidence of S. aureus SSI, stratified by American Society of Anesthesiologists Physical Score classification | Up to 90 days following surgery |
| Incidence of S. aureus SSI, stratified by participating country | Up to 90 days following surgery |
| Magnitude of healthcare utilization associated with S. aureus SSI in terms of: a. Duration of length of stay (LOS) b. Incidence of readmissions, including re-interventions due to S. aureus SSI c. Duration of LOS during readmissions | Up to 90 days following surgery |
Countries
Belgium, Czechia, Estonia, France, Italy, Netherlands, Romania, Serbia, Spain, United Kingdom
Outcome results
None listed