Recruiting
Phase 3

Infection Prophylaxis

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT06126614

Conditions

Periprosthetic Joint Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Chlorhexidine Gluconate

Vancomycin Hydrochloride

Povidone-Iodine

Saline

Study Details

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.

Conditions

Periprosthetic Joint Infection

Study ID

NCT06126614

Start date

May 7, 2024

Status verified date

May, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

21006 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Povidone-Iodine 0.35% Lavage Solution

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.

experimental: Povidone-Iodine 0.35% Lavage Solution and Vancomycin

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.

experimental: Chlorhexidine Gluconate 0.05% Lavage Solution

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.

experimental: Chlorhexidine Gluconate 0.05% Lavage Solution and Vancomycin

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.

active comparator: Saline Lavage Solution

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.

experimental: Saline Lavage Solution and Vancomycin

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.

Interventions

Chlorhexidine Gluconate

0.05% chlorhexidine gluconate solution for irrigation

Vancomycin Hydrochloride

2 grams of topical vancomycin hydrochloride added to the wound

Povidone-Iodine

0.35% povidone-iodine solution for irrigation

Saline

saline for irrigation

Primary outcome measure

  • The number of reoperations due to infection [ Time Frame: Within 1 year of total joint replacement ]

Central Contacts and Locations

Central contacts

Lindsay Maharaj, MSc

905-521-2100maharajli@hhsc.ca

Locations

Hamilton Health Sciences - Juravinski Hospital and Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V 1C3

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Arthroplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2026-05-22.