Infection Prophylaxis in Total Joint Replacement

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06126614

Acronym

PREVENT-iT

Enrollment

21006

Registered

2023-11-13

Start date

2024-05-07

Completion date

2028-11-30

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periprosthetic Joint Infection

Keywords

Arthroplasty

Brief 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.

Interventions

DRUGChlorhexidine Gluconate

0.05% chlorhexidine gluconate solution for irrigation

DRUGVancomycin Hydrochloride

2 grams of topical vancomycin hydrochloride added to the wound

OTHERPovidone-Iodine

0.35% povidone-iodine solution for irrigation

OTHERSaline

saline for irrigation

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The number of reoperations due to infection	Within 1 year of total joint replacement

Secondary

Measure	Time frame
The number of non-operative surgical site infections requiring antibiotics for treatment.	Within 1 year of total joint replacement

Countries

Canada

Contacts

Primary ContactLindsay Maharaj, MSc

maharajli@hhsc.ca905-521-2100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026