Infection Prophylaxis in Total Joint Replacement

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHamilton Health Sciences Corporation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 18 years of age or older.

Undergoing primary or aseptic revision TJR.

No contraindications to study interventions.

Informed consent (participant or substitute decision maker) obtained and willing to comply with the protocol.

Disqualifiers

Received antibiotics for any reason in the two weeks prior to their TJR.

Chronic or acute infection at or near the TJR site.

Prior history of periprosthetic joint infection including any reoperation due to infection.

Undergoing surgery for a diagnosis of a fracture.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Chlorhexidine Gluconate

    Drug

    0.05% chlorhexidine gluconate solution for irrigation

  • Vancomycin Hydrochloride

    Drug

    2 grams of topical vancomycin hydrochloride added to the wound

  • Povidone-Iodine

    Other intervention

    0.35% povidone-iodine solution for irrigation

  • Saline

    Other intervention

    saline for irrigation

Treatment groups

21,006 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Povidone-Iodine 0.35% Lavage SolutionExperimental treatment 1 intervention
Group B: Povidone-Iodine 0.35% Lavage Solution and VancomycinExperimental treatment 2 interventions
Group C: Chlorhexidine Gluconate 0.05% Lavage SolutionExperimental treatment 1 intervention
Group D: Chlorhexidine Gluconate 0.05% Lavage Solution and VancomycinExperimental treatment 2 interventions
Group E: Saline Lavage SolutionActive comparator 1 intervention
Group F: Saline Lavage Solution and VancomycinExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The number of reoperations due to infection

Time frame
Within 1 year of total joint replacement

Secondary outcomes

1

The number of non-operative surgical site infections requiring antibiotics for treatment.

Time frame
Within 1 year of total joint replacement

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hamilton Health Sciences Corporation

Lead sponsor

McMaster University

Collaborator

Ontario Clinical Oncology Group (OCOG)

Collaborator