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Infection Prophylaxis in Total Joint Replacement

NCT06126614 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21006

Last updated 2026-05-22

No results posted yet for this study

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

Interventions

DRUG

Chlorhexidine Gluconate

0.05% chlorhexidine gluconate solution for irrigation

DRUG

Vancomycin Hydrochloride

2 grams of topical vancomycin hydrochloride added to the wound

OTHER

Povidone-Iodine

0.35% povidone-iodine solution for irrigation

OTHER

Saline

saline for irrigation

Sponsors & Collaborators

  • McMaster University

    collaborator OTHER

  • Ontario Clinical Oncology Group (OCOG)

    collaborator OTHER

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Thomas J Wood, MD, FRCSC · Hamilton Health Sciences / McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-07
Primary Completion
2028-11-30
Completion
2028-11-30

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06126614 on ClinicalTrials.gov