Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06126614

Infection Prophylaxis in Total Joint Replacement

Led by Hamilton Health Sciences Corporation · Updated on 2024-09-19

21006

Participants Needed

1

Research Sites

234 weeks

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 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

Official 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
  • Able to provide informed consent or have a substitute decision maker and willing to follow the study protocol
Not Eligible

You will not qualify if you...

  • Received antibiotics within two weeks before joint replacement surgery
  • Chronic or acute infection at or near the joint replacement site
  • History of periprosthetic joint infection or reoperation due to such infection
  • Surgery for a fracture diagnosis
  • Open infected wounds on the affected limb
  • Undergoing bilateral total joint replacement
  • Enrolled in another study that does not allow co-enrollment
  • Previously enrolled in this trial or pilot study
  • Any condition that interferes with study assessments or completion as judged by the investigator

AI-Screening

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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

CONTACT

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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