RecruitingNot ApplicableNCT04600973

Improving Implementation of Evidence-based Approaches and Surveillance to Prevent Bacterial Transmission and Infection

The BASIC Trial: Improving Implementation of Evidence-based Approaches and Surveillance to Prevent Bacterial Transmission and Infection


Sponsor

Trustees of Dartmouth College

Enrollment

6,000 participants

Start Date

Jul 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • operating room conducting orthopedic total joint and spine
  • Surgeons performing orthopedic total joint or spine
  • \- all elective patients undergoing orthopedic total joint and spine

Exclusion Criteria10

  • patients (125 case pairs) per site in the active phase (N=3,000)
  • patients (125 case pairs) per site in the sustainability phase (N=3,000)
  • Total N=6,000
  • orthopedic total joint and spine procedures
  • \- medical centers actively enrolling patients in a bacterial transmission or infection prevention trial
  • 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

Interventions

BEHAVIORALTechnical assistance or team-based coaching

Main comparison in delivering peri-operative preventive strategies against transmission and infection is one on one technical assistance or team-based coaching.


Locations(2)

Mayo Clinic

Rochester, Minnesota, United States

Trustees of Dartmouth College

Hanover, New Hampshire, United States

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NCT04600973


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