Reducing infections after total joint replacement surgery

Prospective Randomized Evaluation of Emerging Novel Treatments for Infection Prophylaxis in Total Joint Replacement (PREVENT-iT)

This study is testing if using special antiseptic solutions and antibiotics can help prevent infections in adults having total joint replacement surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 21006 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hamilton Health Sciences Corporation (Academic / other)
• Locations: 1 site (Hamilton, Ontario)
• Trial ID: NCT06126614 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of using antiseptic solutions and direct antibiotic application to reduce the risk of periprosthetic joint infections in patients undergoing total joint replacements. Participants will be randomized to receive either standard care or the experimental interventions, which include chlorhexidine gluconate, vancomycin hydrochloride, and povidone-iodine. The study focuses on patients aged 18 and older who are undergoing primary or aseptic revision total joint replacement. By comparing infection rates between the two groups, the trial seeks to determine if these interventions can lower the incidence of infections that lead to reoperations.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for primary or aseptic revision total joint replacement.

Not a fit: Patients with recent antibiotic use, existing infections, or a history of periprosthetic joint infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of infections following joint replacement surgeries, leading to better patient outcomes and fewer complications.

How similar studies have performed: Other studies have shown promising results with similar antiseptic and antibiotic approaches in reducing surgical site infections, indicating that this methodology has potential.

Eligibility criteria

Inclusion Criteria:

1. Patients 18 years of age or older.
2. Undergoing primary or aseptic revision TJR.
3. No contraindications to study interventions.
4. Informed consent (participant or substitute decision maker) obtained and willing to comply with the protocol.

Exclusion Criteria:

1. Received antibiotics for any reason in the two weeks prior to their TJR.
2. Chronic or acute infection at or near the TJR site.
3. Prior history of periprosthetic joint infection including any reoperation due to infection.
4. Undergoing surgery for a diagnosis of a fracture.
5. Open infected wounds on affected limb.
6. Undergoing bilateral TJR.
7. Currently enrolled in a study that does not permit co-enrollment.
8. Prior enrollment in the trial including the pilot study
9. Any condition or circumstance, which in the opinion of the Investigator, interferes with assessments or completion of the trial.

Where this trial is running

Hamilton, Ontario

• Hamilton Health Sciences - Juravinski Hospital and Cancer Centre — Hamilton, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Thomas J Wood, MD, FRCSC — Hamilton Health Sciences / McMaster University
• Study coordinator: Lindsay Maharaj, MSc

Conditions Periprosthetic Joint Infection; Arthroplasty