Evaluation of Emerging New Treatments for Infection Prevention in Total Joint Replacement

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

At the end of total joint replacement (TJR) surgery, surgeons wash and clean the surgical wound. This is done to lower the risk of infections. Currently, most surgeons use saline to wash the surgical wound and do not place antibiotics in the wound . However, some recent studies have shown that using povidone-iodine and chlorhexidine-based solutions (both are types of antiseptics) to wash the surgical site and placing antibiotics directly into the wound may be effective in reducing infections in TJR surgery compared to saline and no antibiotics. However, no study has determined which solution is better at reducing the number of infections in patients undergoing TJR. The investigators also do not know if the addition of antibiotics applied to the wound will decrease infections. Currently, there are no surgical guidelines around infection prevention in total joint replacement. A large scale, multi-site, pragmatic 3 x 2 factorial randomized controlled trial is need that compares these six treatment groups. However, before this, a smaller pilot study must be conducted to determine the feasibility of a larger study. PREVENT-iT will address these important gaps in knowledge and clinical practice.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Treatments: Anti-Bacterial Agents; Chlorhexidine; Pharmaceutical Solutions; Povidone; Povidone-Iodine

Criteria

Inclusion Criteria:

1. Patients 18 years of age or older.

2. Undergoing primary or revision TJR.

3. Informed consent obtained.

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 PJI.

4. Undergoing surgery for a diagnosis of a fracture.

5. Open wounds on affected limb.

6. Undergoing bilateral TJR.

7. Medical contraindication to povidone-iodine.

8. Medical contraindication to chlorhexidine.

9. Medical contraindication to vancomycin.

10. Current or anticipated incarceration.

11. Terminal illness with expected survival less than 90 days.

12. Currently enrolled in a study that does not permit co-enrollment.

13. Unable to obtain informed consent due to language barriers.

14. Problems, in the judgment of study personnel, with maintaining follow-up with the patient.

15. Prior enrollment in the trial.

16. Other reason to exclude the patient, as approved by the Methods Centre.