PREVENT-iT: Infection Prophylaxis in Total Joint Replacement

Sponsor

Hamilton Health Sciences Corporation (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06126614

Collaborator

McMaster University (Other), Ontario Clinical Oncology Group (OCOG) (Other)

21,006

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periprosthetic Joint Infection	Drug: Chlorhexidine Gluconate Drug: Vancomycin Hydrochloride Other: Povidone-Iodine Other: Saline	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

21006 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2028

Anticipated Study Completion Date :

Nov 1, 2028

Arms and Interventions

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.	Drug: Vancomycin Hydrochloride 2 grams of topical vancomycin hydrochloride added to the wound Other: Povidone-Iodine 0.35% povidone-iodine solution for irrigation
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: Chlorhexidine Gluconate 0.05% chlorhexidine gluconate solution for irrigation Drug: Vancomycin Hydrochloride 2 grams of topical vancomycin hydrochloride added to the wound
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

Outcome Measures

Primary Outcome Measures

The number of reoperations due to infection [Within 1 year of total joint replacement]

Secondary Outcome Measures

The number of non-operative surgical site infections requiring antibiotics for treatment. [Within 1 year of total joint replacement]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.