Periprosthetic Joint InfectionPhase 3PREVENT-iTNCT06126614
Infection Prophylaxis in Total Joint Replacement
A Phase 3 study testing Chlorhexidine Gluconate, Vancomycin Hydrochloride and Povidone-Iodine in people with Periprosthetic Joint Infection, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Joint Infection
- What is being tested?
- Chlorhexidine Gluconate, Vancomycin Hydrochloride and Povidone-Iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21,006 participants
- Where
- 1 siteCanada
- Study dates
- 7 May 2024to Nov 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hamilton Health Sciences - Juravinski Hospital and Cancer Centre
Hamilton, Ontario, L8V 1C3
About this study
Official title: 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.
- Conditions
- Periprosthetic Joint Infection
- Being tested
- Chlorhexidine Gluconate, Vancomycin Hydrochloride, Povidone-Iodine, Saline
- Keywords
- Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine GluconateDrug
0.05% chlorhexidine gluconate solution for irrigation
Vancomycin HydrochlorideDrug
2 grams of topical vancomycin hydrochloride added to the wound
Povidone-IodineOther
0.35% povidone-iodine solution for irrigation
SalineOther
saline for irrigation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Vancomycin Hydrochloride; Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of reoperations due to infection
Measured: Within 1 year of total joint replacement
Secondary outcomes (1)
The number of non-operative surgical site infections requiring antibiotics for treatment.
Measured: Within 1 year of total joint replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start7 May 2024
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprosthetic Joint InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 21,006 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, Ontario Clinical Oncology Group (OCOG)
- Responsible party
- Sponsor
- Investigators
- Thomas J Wood, MD, FRCSC, Principal investigator, Hamilton Health Sciences / McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126614
- Sponsor's protocol ID
- PiT-2023
- Acronym
- PREVENT-iT
- Status last verified
- May 2026
- First submitted
- 6 Nov 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Evaluation of Emerging Novel Treatments for Infection Prophylaxis in Total Joint Replacement (PREVENT-iT)
- ClinicalTrials.gov ID
- NCT06126614
- Acronym / sponsor ID
- PREVENT-iT / PiT-2023
- Conditions
- Periprosthetic Joint Infection
- Keywords
- Arthroplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21,006 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- McMaster University, Ontario Clinical Oncology Group (OCOG)
- Study start
- 7 May 2024 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Povidone-Iodine 0.35% Lavage Solution | Experimental | Other: Povidone-IodineThe 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. |
| Povidone-Iodine 0.35% Lavage Solution and Vancomycin | Experimental | Drug: Vancomycin Hydrochloride, Other: Povidone-IodineThe 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. |
| Chlorhexidine Gluconate 0.05% Lavage Solution | Experimental | Drug: Chlorhexidine GluconateThe 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. |
| Chlorhexidine Gluconate 0.05% Lavage Solution and Vancomycin | Experimental | Drug: Chlorhexidine Gluconate, Drug: Vancomycin HydrochlorideThe 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. |
| Saline Lavage Solution | Active comparator | Other: SalineThe 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. |
| Saline Lavage Solution and Vancomycin | Experimental | Drug: Vancomycin Hydrochloride, Other: SalineThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine Gluconate0.05% chlorhexidine gluconate solution for irrigation | Drug | Chlorhexidine Gluconate 0.05% Lavage Solution, Chlorhexidine Gluconate 0.05% Lavage Solution and Vancomycin |
| Vancomycin Hydrochloride2 grams of topical vancomycin hydrochloride added to the wound | Drug | Chlorhexidine Gluconate 0.05% Lavage Solution and Vancomycin, Povidone-Iodine 0.35% Lavage Solution and Vancomycin, Saline Lavage Solution and Vancomycin |
| Povidone-Iodine0.35% povidone-iodine solution for irrigation | Other | Povidone-Iodine 0.35% Lavage Solution, Povidone-Iodine 0.35% Lavage Solution and Vancomycin |
| Salinesaline for irrigation | Other | Saline Lavage Solution, Saline Lavage Solution and Vancomycin |
Primary outcome
The number of reoperations due to infection
Time frame: Within 1 year of total joint replacement
1 secondary outcome
The number of non-operative surgical site infections requiring antibiotics for treatment.
Time frame: Within 1 year of total joint replacement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas J Wood, MD, FRCSC principal investigator
Hamilton Health Sciences / McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chlorhexidine Gluconate, Vancomycin Hydrochloride and Povidone-Iodine in people with Periprosthetic Joint Infection, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lindsay Maharaj, MSc (905-521-2100 ext. 43814, maharajli@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of reoperations due to infection (time frame: Within 1 year of total joint replacement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.