Infection Prophylaxis in Total Joint Replacement

Study Overview
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Brief Summary
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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.

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

Conditions
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Periprosthetic Joint Infection

Intervention / Treatment
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* Drug: Chlorhexidine Gluconate
* Drug: Vancomycin Hydrochloride
* Other: Povidone-Iodine
* Other: Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Povidone-Iodine 0.35% Lavage Solution<br>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<br>* 0.35% povidone-iodine solution for irrigation<br>|
| Experimental: Povidone-Iodine 0.35% Lavage Solution and Vancomycin<br>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<br>* 2 grams of topical vancomycin hydrochloride added to the wound<br>Other: Povidone-Iodine<br>* 0.35% povidone-iodine solution for irrigation<br>|
| Experimental: Chlorhexidine Gluconate 0.05% Lavage Solution<br>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<br>* 0.05% chlorhexidine gluconate solution for irrigation<br>|
| Experimental: Chlorhexidine Gluconate 0.05% Lavage Solution and Vancomycin<br>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<br>* 0.05% chlorhexidine gluconate solution for irrigation<br>Drug: Vancomycin Hydrochloride<br>* 2 grams of topical vancomycin hydrochloride added to the wound<br>|
| Active Comparator: Saline Lavage Solution<br>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<br>* saline for irrigation<br>|
| Experimental: Saline Lavage Solution and Vancomycin<br>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<br>* 2 grams of topical vancomycin hydrochloride added to the wound<br>Other: Saline<br>* saline for irrigation<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty