Infection Prophylaxis in Total Joint Replacement

NCT06126614 | Recruiting Phase 3 DMC

• 1 other identifier: PiT-2023
• Study Type: interventional
• Target: 21,006
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Arthroplasty

Outcome Measures

Primary Outcomes (1)

• The number of reoperations due to infection

  Within 1 year of total joint replacement

Secondary Outcomes (1)

• The number of non-operative surgical site infections requiring antibiotics for treatment.

  Within 1 year of total joint replacement

Study Arms (6)

Povidone-Iodine 0.35% Lavage Solution

EXPERIMENTAL

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

Povidone-Iodine 0.35% Lavage Solution and Vancomycin

EXPERIMENTAL

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.

Drug: Vancomycin Hydrochloride; Other: Povidone-Iodine

Chlorhexidine Gluconate 0.05% Lavage Solution

EXPERIMENTAL

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

Chlorhexidine Gluconate 0.05% Lavage Solution and Vancomycin

EXPERIMENTAL

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: Chlorhexidine Gluconate; Drug: Vancomycin Hydrochloride

Saline Lavage Solution

ACTIVE COMPARATOR

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 Lavage Solution and Vancomycin

EXPERIMENTAL

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; Other: Saline

Interventions

Chlorhexidine Gluconate DRUG

0.05% chlorhexidine gluconate solution for irrigation

Chlorhexidine Gluconate 0.05% Lavage Solution; Chlorhexidine Gluconate 0.05% Lavage Solution and Vancomycin

Vancomycin Hydrochloride DRUG

2 grams of topical vancomycin hydrochloride added to the wound

Chlorhexidine Gluconate 0.05% Lavage Solution and Vancomycin; Povidone-Iodine 0.35% Lavage Solution and Vancomycin; Saline Lavage Solution and Vancomycin

Povidone-Iodine OTHER

0.35% povidone-iodine solution for irrigation

Povidone-Iodine 0.35% Lavage Solution; Povidone-Iodine 0.35% Lavage Solution and Vancomycin

Saline OTHER

saline for irrigation

Saline Lavage Solution; Saline Lavage Solution and Vancomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• McMaster University: collaborator
• Ontario Clinical Oncology Group (OCOG): collaborator

Study Sites (1)

Hamilton Health Sciences - Juravinski Hospital and Cancer Centre

Hamilton, Ontario, L8V 1C3, Canada

RECRUITING

MeSH Terms

Interventions

chlorhexidine gluconate; Vancomycin; Povidone-Iodine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• Thomas J Wood, MD, FRCSC

  Hamilton Health Sciences / McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay Maharaj, MSc

CONTACT

905-521-2100; maharajli@hhsc.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: May 7, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)