Infection Prophylaxis in Total Joint Replacement (PREVENT-iT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periprosthetic Joint Infection
• Intervention / Treatment: Other: Povidone-Iodine; Drug: Vancomycin Hydrochloride; Drug: Chlorhexidine Gluconate; Other: Saline

• Study Type: Interventional
• Enrollment (Estimated): 21006
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Lindsay Maharaj, MSc; Phone Number: 43814 905-521-2100; Email: maharajli@hhsc.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V 1C3
      • Recruiting
      • Hamilton Health Sciences - Juravinski Hospital and Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients 18 years of age or older.
2. Undergoing primary or aseptic revision TJR.
3. No contraindications to study interventions.
4. Informed consent (participant or substitute decision maker) obtained and willing to comply with the protocol.

Exclusion Criteria:

1. Received antibiotics for any reason in the two weeks prior to their TJR.
2. Chronic or acute infection at or near the TJR site.
3. Prior history of periprosthetic joint infection including any reoperation due to infection.
4. Undergoing surgery for a diagnosis of a fracture.
5. Open infected wounds on affected limb.
6. Undergoing bilateral TJR.
7. Currently enrolled in a study that does not permit co-enrollment.
8. Prior enrollment in the trial including the pilot study
9. Any condition or circumstance, which in the opinion of the Investigator, interferes with assessments or completion of the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Povidone-Iodine 0.35% Lavage Solution; The study lavage solution (povidone-iodine) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline.	Other: Povidone-Iodine; 0.35% povidone-iodine solution for irrigation
Experimental: Povidone-Iodine 0.35% Lavage Solution and Vancomycin; The study lavage solution (povidone-iodine) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. Two grams of vancomycin is applied to the deep joint (to arthrotomy in knee and deep to fascia in hip) following removal of the study lavage solution and immediately prior to closure. The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline.	Other: Povidone-Iodine; 0.35% povidone-iodine solution for irrigation; Drug: Vancomycin Hydrochloride; 2 grams of topical vancomycin hydrochloride added to the wound
Experimental: Chlorhexidine Gluconate 0.05% Lavage Solution; The study lavage solution (chlorhexidine-gluconate) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline.	Drug: Chlorhexidine Gluconate; 0.05% chlorhexidine gluconate solution for irrigation
Experimental: Chlorhexidine Gluconate 0.05% Lavage Solution and Vancomycin; The study lavage solution (chlorhexidine gluconate) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. Two grams of vancomycin is applied to the deep joint (to arthrotomy in knee and deep to fascia in hip) following removal of the study lavage solution and immediately prior to closure. The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline.	Drug: Vancomycin Hydrochloride; 2 grams of topical vancomycin hydrochloride added to the wound; Drug: Chlorhexidine Gluconate; 0.05% chlorhexidine gluconate solution for irrigation
Active Comparator: Saline Lavage Solution; The study lavage solution (saline) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. The study lavage solution will be a total volume of 1 litre.	Other: Saline; saline for irrigation
Experimental: Saline Lavage Solution and Vancomycin; The study lavage solution (saline) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. Two grams of vancomycin is applied to the deep joint (to arthrotomy in knee and deep to fascia in hip) following removal of the study lavage solution and immediately prior to closure.	Drug: Vancomycin Hydrochloride; 2 grams of topical vancomycin hydrochloride added to the wound; Other: Saline; saline for irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of reoperations due to infection	Within 1 year of total joint replacement

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of non-operative surgical site infections requiring antibiotics for treatment.	Within 1 year of total joint replacement

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Collaborators: McMaster University; Ontario Clinical Oncology Group (OCOG)
• Investigators: Principal Investigator: Thomas J Wood, MD, FRCSC, Hamilton Health Sciences / McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Arthroplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Peptides; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Carbohydrates; Inorganic Chemicals; Chlorine Compounds; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Glycoconjugates; Pyrrolidines; Glycopeptides; Sodium Compounds; Plastics; Chlorides; Hydrochloric Acid; Pyrrolidinones; Iodine Compounds; Iodophors; Polyvinyls; Vinyl Compounds; Povidone; Vancomycin; Povidone-Iodine; chlorhexidine gluconate; Sodium Chloride
• Other Study ID Numbers: PiT-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No