Improving Implementation of Evidence-based Approaches and Surveillance to Prevent Bacterial Trans… (NCT04600973) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Improving Implementation of Evidence-based Approaches and Surveillance to Prevent Bacterial Transmission and Infection
United States6,000 participantsStarted 2021-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.