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NCT Number: NCT06126614

Infection Prophylaxis in Total Joint Replacement

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.

Recruiting

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Key information

Conditions

Periprosthetic Joint Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamilton Health Sciences - Juravinski Hospital and Cancer Centre

Hamilton, Ontario, L8V 1C3, Canada

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Open infected wounds on affected limb.
  • Undergoing bilateral TJR.
  • Currently enrolled in a study that does not permit co-enrollment.
  • Prior enrollment in the trial including the pilot study
  • Any condition or circumstance, which in the opinion of the Investigator, interferes with assessments or completion of the trial.

Treatment and study plan

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

0.35% povidone-iodine solution for irrigation

Saline

Other

saline for irrigation

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lindsay Maharaj, MSc

CONTACT

[email protected]

905-521-2100 ext. 43814

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • McMaster University
  • Ontario Clinical Oncology Group (OCOG)

Registry information

Official study title

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

Acronym: PREVENT-iT

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 13, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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