Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID06126614

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

Led by Hamilton Health Sciences Corporation · Updated on 2026-05-22

21006

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

H

Hamilton Health Sciences Corporation

Lead Sponsor

M

McMaster University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Osteoarthritis (OA) is a common cause of disability worldwide, affecting over 500 million people. Total joint replacements (TJR) are often used when other treatments fail, but infection is the main cause of joint replacement failure, leading to more complex repeat surgeries. This clinical trial aims to evaluate whether using antiseptic washes and placing antibiotics directly into the surgical wound can reduce infections requiring reoperation after hip or knee replacements. Participants undergoing primary or aseptic revision total joint replacements will be randomly assigned to one of six groups. These groups receive different combinations of antiseptic lavage solutions—povidone-iodine, chlorhexidine gluconate, or saline—and may also receive topical vancomycin antibiotic applied directly to the joint wound before closure. The antiseptic solution is poured into the surgical site and left for 3 minutes before removal. The study compares infection rates across these treatment combinations. During the year following surgery, participants will be monitored for infections that require reoperation or antibiotic treatment. Researchers will track the number of infections in each group to assess if the treatments reduce infection risk. The study includes regular follow-ups and evaluations of surgical site infections to determine outcomes and ensure participant safety over the 12-month period after joint replacement surgery.

CONDITIONS

Brief Title

Infection Prophylaxis in Total Joint Replacement

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years of age or older
  • Undergoing primary or aseptic revision total joint replacement
  • No contraindications to study interventions
  • Informed consent obtained and willingness to follow the study protocol
Not Eligible

You will not qualify if you...

  • Received antibiotics for any reason in the two weeks before surgery
  • Chronic or acute infection at or near the joint replacement site
  • Prior history of periprosthetic joint infection or reoperation due to infection
  • Surgery due to a fracture diagnosis
  • Open infected wounds on the affected limb
  • Undergoing bilateral total joint replacement
  • Currently enrolled in a study that prohibits co-enrollment
  • Previous enrollment in this trial or pilot study
  • Any condition that interferes with assessments or completion of the trial as judged by the Investigator

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo total joint replacement surgery where one of several study lavage solutions is used during surgery. The lavage solution is poured into the joint, left for 3 minutes, then removed by suction. For some participants, vancomycin is also applied to the deep joint immediately prior to closure.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - Up to 1 year after total joint replacement

Participants are monitored for signs of infection and recovery after surgery, including tracking any reoperations or infections requiring antibiotics.

Follow-up visits as scheduled by treating team

Trial Site Locations

Total: 1 location

1

Hamilton Health Sciences - Juravinski Hospital and Cancer Centre

Hamilton, Ontario, Canada, L8V 1C3

Actively Recruiting

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Research Team

L

Lindsay Maharaj, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

PREVENTION

Number of Arms

6

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