Improving prevention of surgical site infections caused by resistant bacteria
The BASIC Trial: Improving Implementation of Evidence-based Approaches and Surveillance to Prevent Bacterial Transmission and Infection
This study is testing a new program to see if it can help prevent infections from tough bacteria in patients having orthopedic surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Trustees of Dartmouth College Academic / other |
| Locations | 2 sites (Rochester, Minnesota and 1 other locations) |
| Trial ID | NCT04600973 on ClinicalTrials.gov |
What this trial studies
This study aims to implement a multifaceted, evidence-based program to prevent surgical site infections (SSIs) caused by ESKAPE pathogens during orthopedic total joint and spine procedures. The program includes enhanced perioperative preventive measures and surveillance using pathogen cluster detection software to reduce bacterial transmission and SSIs. By randomizing participating sites, the study will evaluate the effectiveness of each component of the program and identify optimal strategies for broader implementation. The goal is to improve patient safety for millions undergoing surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are elective patients undergoing orthopedic total joint and spine procedures.
Not a fit: Patients who do not require anesthesia, lack an incision, or have severe allergies to antiseptics may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce the incidence of surgical site infections, improving patient outcomes and reducing healthcare costs.
How similar studies have performed: Previous studies have shown success with similar multifaceted approaches to infection prevention, indicating potential for positive outcomes in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota and 1 other locations
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Trustees of Dartmouth College — Hanover, New Hampshire, United States (Recruiting)
Study contacts
- Principal investigator: Jeremiah R Brown, PhD — Trustees of Dartmouth College
- Study coordinator: Jeremiah R Brown, PhD
- Email: jbrown@dartmouth.edu
- Phone: 603-646-5409
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.