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Active Not Recruiting
NCT04600973
Improving Implementation of Evidence-based Approaches and Surveillance to Prevent Bacterial Transmission and Infection
Conditions: Infection
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 6000
Sponsor: Trustees of Dartmouth College
Location: Mayo Clinic Rochester Minnesota
Summary
Surgical site infections (SSIs) are associated with increased patient morbidity, mortality, and healthcare costs. ESKAPE (Enterococcus, S. aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) pathogens are particularly pathogenic because they have increased capacity to acquire resistance and virulence traits. The investigators have proven that a multifaceted program involving improved basic perioperative preventive measures can generate substantial reductions in S. aureus transmission and significant reductions in SSIs (88% reduction as compared to usual care). In this study, the investigators aim to examine the relative effectiveness of each component of this program in controlling ESKAPE transmission and reducing SSIs and to identify an optimal implementation strategy for national dissemination. Randomization occurs at the site level, and sites adopt preventative programs. This work will improve perioperative patient safety for the 51 million patients who undergo surgery each year.
Eligibility Criteria
Site Inclusion and Exclusion Criteria.
* 250 patients (125 case pairs) per site in the active phase (N=3,000)
* 250 patients (125 case pairs) per site in the sustainability phase (N=3,000)
* Total N=6,000
* orthopedic total joint and spine procedures
Site Inclusion Criteria:
* operating room conducting orthopedic total joint and spine
* Surgeons performing orthopedic total joint or spine
Site Exclusion Criteria:
\- medical centers actively enrolling patients in a bacterial transmission or infection prevention trial
Patient Inclusion Criteria:
\- all elective patients undergoing orthopedic total joint and spine
Exclusion Criteria:
* no requirement for anesthesia and/or placement of a peripheral intravenous catheter
* lack of incision or informed, written consent
* an allergy to chlorhexidine
* povidone iodine or isopropyl alcohol
* ASA health classification status\>5
Source: ClinicalTrials.gov (NCT04600973). StuddyBuddy aggregates publicly available trial information.