Infection Prophylaxis in Total Joint Replacement

Periprosthetic Joint Infection Clinical Trial

— PREVENT-iT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06126614
• Other study ID #: PiT-2023
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: November 2023
• Est. completion date: November 2028

Study information

• Verified date: November 2023
• Source: Hamilton Health Sciences Corporation
• Contact: Laura Puri
• Phone: 905-521-2100
• Email: puri[@]hhsc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Osteoarthritis (OA) is the most common cause of disability in older adults worldwide affecting 7% of the global population, or more than 500 million people globally. Total joint replacements (TJR) can help bring relief to those with osteoarthritis when other treatment options are no longer helpful. Infection is the main reason hip and knee replacements "fail". Failure leads to repeat surgeries that are often more complicated and less likely to be successful than the first surgery. Reducing the risk of infection is extremely important, antiseptic washes and antibiotics may help us do that. After joint replacement surgery, orthopaedic surgeons wash and clean the surgical wound to lower the risk of infection. The goal of this clinical trial is to determine if the use of antiseptic solutions to wash the surgical site and placing an antibiotic directly into the wound will reduce the number of infections requiring reoperation. Patients having total joint replacements will be randomized (like flipping a coin) to receive 6 possible combinations of washes and / or antibiotics. Participants will be followed for one year after TJR to compare the rate of infection in each group.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 21006
• Est. completion date: November 2028
• Est. primary completion date: November 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Periprosthetic Joint Infection

Intervention

Drug:
• Chlorhexidine Gluconate
0.05% chlorhexidine gluconate solution for irrigation
• Vancomycin Hydrochloride
2 grams of topical vancomycin hydrochloride added to the wound

Other:
• Povidone-Iodine
0.35% povidone-iodine solution for irrigation
• Saline
saline for irrigation

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	McMaster University, Ontario Clinical Oncology Group (OCOG)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of reoperations due to infection		Within 1 year of total joint replacement
Secondary	The number of non-operative surgical site infections requiring antibiotics for treatment.		Within 1 year of total joint replacement