Comparing 6 approaches for periprosthetic joint infection
Official title: Infection Prophylaxis in Total Joint Replacement
Prospective Randomized Evaluation of Emerging Novel Treatments for Infection Prophylaxis in Total Joint Replacement (PREVENT-iT)
- Phase 3
- 6 groups
- One site, in Hamilton
- Recruiting
Interventions (4)
- Medication
Chlorhexidine Gluconate
0.05% chlorhexidine gluconate solution for irrigation
- Medication
Vancomycin Hydrochloride
2 grams of topical vancomycin hydrochloride added to the wound
- Other intervention
Povidone-Iodine
0.35% povidone-iodine solution for irrigation
- Other intervention
Saline
saline for irrigation
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Hamilton Health Sciences - Juravinski Hospital and Cancer Centre
Hamilton, Ontario
Eligibility Criteria
See who this study is looking for13 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Patients 18 years of age or older.
- +Undergoing primary or aseptic revision TJR.
- +No contraindications to study interventions.
- +Informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → (participant or substitute decision maker) obtained and willing to comply with the protocolProtocolThe detailed plan a study must follow.Read more →.
Exclusion
- −Received antibiotics for any reason in the two weeks prior to their TJR.
- −Chronic or acute infection at or near the TJR siteTrial siteA hospital or clinic where a study is actually run.Read more →.
- −Prior history of periprosthetic joint infection including any reoperation due to infection.
- −Open infected wounds on affected limb.
- −Undergoing bilateral TJR.
- −Currently enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → 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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, interferes with assessments or completion of the trial.
- −Undergoing surgery for a diagnosis of a fracture.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 6 groups in this study.
Group A receives Povidone-Iodine.
Registry label: A: Povidone-Iodine 0.35% Lavage Solution
Group B receives Povidone-Iodine, together with one or more of: Vancomycin Hydrochloride.
Registry label: B: Povidone-Iodine 0.35% Lavage Solution and Vancomycin
Group C receives Chlorhexidine Gluconate.
Registry label: C: Chlorhexidine Gluconate 0.05% Lavage Solution
Group D receives Chlorhexidine Gluconate, together with one or more of: Vancomycin Hydrochloride.
Registry label: D: Chlorhexidine Gluconate 0.05% Lavage Solution and Vancomycin
Group E, the comparison group, receives Saline.
Registry label: E: Saline Lavage Solution
Group F receives Saline, together with one or more of: Vancomycin Hydrochloride.
Registry label: F: Saline Lavage Solution and Vancomycin
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 21,006 people.
The study is currently expected to finish around November 2028.
The main measurement is taken over: Within 1 year of total joint replacement.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
The number of reoperations due to infection — measured over Within 1 year of total joint replacement.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06126614 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Chlorhexidine GluconateDrug
0.05% chlorhexidine gluconate solution for irrigation
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Vancomycin HydrochlorideDrug
2 grams of topical vancomycin hydrochloride added to the wound
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Povidone-IodineOther
0.35% povidone-iodine solution for irrigation
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About SalineOther
saline for irrigation
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Within 1 year of total joint replacement.
The study as a whole is currently expected to finish around 2028-11.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 21,006 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Hamilton, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.