Infection Prophylaxis in Total Joint Replacement (PREVENT-iT)

Hamilton Health Sciences (HHS)

Status and phase: Enrolling; Phase 3

Conditions: Periprosthetic Joint Infection

Treatments: Other: Povidone-Iodine; Drug: Chlorhexidine Gluconate; Other: Saline; Drug: Vancomycin Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT06126614

PiT-2023

Details and patient eligibility

About

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.

Enrollment: 21,006 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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21,006 participants in 6 patient groups

Povidone-Iodine 0.35% Lavage Solution

Experimental group

Description:

The study lavage solution (povidone-iodine) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline.

Treatment:

Other: Povidone-Iodine

Povidone-Iodine 0.35% Lavage Solution and Vancomycin

Experimental group

Description:

The study lavage solution (povidone-iodine) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. Two grams of vancomycin is applied to the deep joint (to arthrotomy in knee and deep to fascia in hip) following removal of the study lavage solution and immediately prior to closure. The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline.

Treatment:

Drug: Vancomycin Hydrochloride

Other: Povidone-Iodine

Chlorhexidine Gluconate 0.05% Lavage Solution

Experimental group

Description:

The study lavage solution (chlorhexidine-gluconate) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline.

Treatment:

Drug: Chlorhexidine Gluconate

Chlorhexidine Gluconate 0.05% Lavage Solution and Vancomycin

Experimental group

Description:

The study lavage solution (chlorhexidine gluconate) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. Two grams of vancomycin is applied to the deep joint (to arthrotomy in knee and deep to fascia in hip) following removal of the study lavage solution and immediately prior to closure. The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline.

Treatment:

Drug: Vancomycin Hydrochloride

Drug: Chlorhexidine Gluconate

Saline Lavage Solution

Active Comparator group

Description:

The study lavage solution (saline) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. The study lavage solution will be a total volume of 1 litre.

Treatment:

Other: Saline

Saline Lavage Solution and Vancomycin

Experimental group

Description:

The study lavage solution (saline) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. Two grams of vancomycin is applied to the deep joint (to arthrotomy in knee and deep to fascia in hip) following removal of the study lavage solution and immediately prior to closure.

Treatment:

Drug: Vancomycin Hydrochloride

Other: Saline