CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare two types of solutions (chlorhexidine gluconate-alcohol solution or povidone-iodine solution) that help eliminate harmful bacteria on the skin at the time of surgery. The main outcome of interest is: • the need for re-operation for a wound complication or an infection of the prosthetic joint within one year after surgery. Participants will be contacted at two time points after surgery to complete a 5-minute survey: after 30 days, and after 1 year. If you decide to participate, you will be randomly assigned (like flipping a coin) by a computer, to one of the possible interventions. You will be told which group you have been assigned to.

Detailed Description
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In this trial, participants will be assigned randomly to have their surgical skin site prepared for surgery with either chlorhexidine gluconate-alcohol solution or povidone-iodine solution. These are two types of solutions that have antiseptic properties, which means they help eliminate harmful bacteria on the skin at the time of surgery, and therefore, reduce the risk of infection. Surgeons routinely use either chlorhexidine-based or iodine-based skin preparation solutions at the time of surgery to sterilize the surgical area. However, we don't know which one works best for patients having revision joint replacement surgery. There is a small chance of having an allergic reaction to the chlorhexidine or iodine, but there is no additional risk by participating in this study, as these skin preparation solutions are routinely used in practice. The main outcome of interest is the need for re-operation for a wound complication or an infection of the prosthetic joint within one year after surgery. Other key outcomes are surgical site infection, mortality, and readmission to hospital. Participants will be contacted 30 days after surgery to complete a survey online, by phone, or in person, which will take approximately 5 minutes to complete. All other outcome data will be collected by phone call, health records, routine hospital monitoring, or electronic registry data at thirty days and one year after surgery. You may choose to participate in this trial, or not. If you decide to participate, you will be randomly assigned (like flipping a coin) by a computer, to one of the possible interventions. You will be told which group you have been assigned to. Participating in this program is your choice (i.e., is voluntary). You have the right to choose not to participate, or to stop participating in this program at any time. Your decision will not affect the care you receive at this time, or in the future. As part of this program, we will use data that is already routinely collected from your hospital stay for administrative and quality-improvement purposes. We will collect your OHIP number to securely link the records we collect to other databases already collected. We will also collect your first and last name, email address and phone number, for follow-up survey purposes. The person conducting this study and other study staff will keep the information they see or receive about you confidential. Your de-identified study information will be kept in a secure and confidential location and then destroyed according to institutional policy. You will not be paid for taking part in this study and there will be no costs associated with participation. If you agree to take part, there may or may not be any direct benefit to you. You will receive a Research Study Information Sheet for your reference. The Research Ethics Board that oversees the ethical conduct of this study may review your relevant study records for audit purposes.

Official Title
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CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee - A Vanguard Randomized Controlled Registry Trial (CLEAN Joint Trial)

Conditions
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Aseptic Revision Total Hip Arthroplasty, Total Knee Arthroplasty With Exchange of at Least One Prosthetic Component

Intervention / Treatment
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* Drug: surgical antiseptic skin preparation with either chlorhexidine or iodine-based solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years or older Scheduled to undergo aseptic revision total hip arthroplasty or total knee arthroplasty with exchange of at least one prosthetic component Exclusion Criteria: Revision for prosthetic joint infection or wound complication Known history of previous prosthetic joint infection in the operative joint Any degree of clinical concern for prosthetic joint infection History of allergy to iodine, chlorhexidine, or alcohol

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: Parallel Assignment
Interventional Model Description: This is a multicentre, pragmatic, open label, 2-arm parallel-group Vanguard feasibility RCT.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chlorhexidine gluconate-alcohol solution<br>Chlorhexidine gluconate-alcohol solution is a type of solution that has antiseptic properties, which means it helps to eliminate harmful bacteria on the skin at the time of surgery, and therefore, reduce the risk of infection. For participants in this arm, their surgeons will use chlorhexidine-based skin preparation solutions at the time of surgery to sterilize the surgical area. | Drug: surgical antiseptic skin preparation with either chlorhexidine or iodine-based solution<br>* Patients will be randomized to receive surgical antiseptic skin preparation with either chlorhexidine or iodine-based solution. Specifically, the first treatment arm will undergo skin antisepsis with 4% chlorhexidine gluconate pre-wash, followed by 2% chlorhexidine gluconate with 70% isopropyl alcohol skin preparation. The second treatment arm will undergo skin antisepsis with 7.5% povidone-iodine detergent pre-wash, followed by 10% povidone-iodine skin preparation.<br>|
| Active Comparator: Povidone-iodine solution<br>Povidone-iodine solution is a type of solution that has antiseptic properties, which means it helps to eliminate harmful bacteria on the skin at the time of surgery, and therefore, reduce the risk of infection. For participants in this arm, their surgeons will use iodine-based skin preparation solutions at the time of surgery to sterilize the surgical area. | Drug: surgical antiseptic skin preparation with either chlorhexidine or iodine-based solution<br>* Patients will be randomized to receive surgical antiseptic skin preparation with either chlorhexidine or iodine-based solution. Specifically, the first treatment arm will undergo skin antisepsis with 4% chlorhexidine gluconate pre-wash, followed by 2% chlorhexidine gluconate with 70% isopropyl alcohol skin preparation. The second treatment arm will undergo skin antisepsis with 7.5% povidone-iodine detergent pre-wash, followed by 10% povidone-iodine skin preparation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of accrual | Average number of patients enrolled per month: feasible if 10 or more on average | 2 years from the start of the study | 
| Ability to deliver intervention the patient is randomized to receive | Feasible if >90% of patients receive correct intervention | 2 years from the start of the study | 
| Ability to collect complete data from participants: | Feasible if >80% of data is collected. | 2 years from the start of the study | 
| 4. To estimate the incidence of reoperation for wound complication or PJI at one year | a) Number of reoperations for wound complication or PJI within one year in each group | 2 years from the start of the study | 
| Ability to link collected outcome data with ICES datasets | Feasible if linkage is possible in >90% of participants | 2 years from the start of the study | 
| Validation of the accuracy of outcome data collected through ICES | a) Valid if >90% agreement (sensitivity, specificity, positive predictive value, negative predictive value) for each outcome (collected at follow-up) | 2 years from the start of the study |