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Study on Infection Prevention in Joint Replacement Surgery Using Povidone, Chlorhexidine, and Vancomycin for Adult Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients undergoing total joint replacement (TJR) surgery, which involves replacing a damaged joint, such as a hip or knee, with an artificial one. The study aims to explore new treatments to prevent infections after these surgeries. Infections can be a serious complication, sometimes requiring additional surgery to address them. The trial will compare different solutions used during surgery to see if they can reduce the risk of infection within 12 months after the procedure.

Participants in the study will receive one of several treatments. One group will receive a solution containing povidone, a type of antiseptic, while another group will receive a solution with chlorhexidine, which is also used to kill bacteria. There is also a group that will receive vancomycin, an antibiotic, applied locally during surgery. These treatments will be compared to a standard saline solution, which is a simple saltwater solution commonly used in medical settings. The purpose is to determine if these treatments can lower the chances of needing another surgery due to infection.

The study will follow participants for up to 12 months after their surgery to monitor for any infections that might require reoperation. By comparing the outcomes of the different treatment groups, researchers hope to find more effective ways to prevent infections in patients undergoing TJR surgery. This could lead to improved recovery and fewer complications for future patients undergoing similar procedures.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the trial's purpose and procedures. You will be asked to provide consent to participate.

    You will be assessed to ensure you meet the criteria for participation, which includes being 18 years or older and undergoing primary or aseptic revision total joint replacement (TJR) surgery.

  2. Step 2

    Pre-surgery preparation

    Before your surgery, you will receive a solution containing chlorhexidine for skin preparation. This is applied to reduce the risk of infection.

    The solution is used on the skin and is part of the standard preparation for surgery.

  3. Step 3

    Surgery and treatment

    During your surgery, you may receive an irrigation solution containing either 0.35% povidone-iodine (PI) or 0.05% chlorhexidine. This is used to clean the surgical area and help prevent infection.

    Additionally, vancomycin may be applied locally to further reduce the risk of infection. This is a medication used to prevent bacterial infections.

  4. Step 4

    Post-surgery follow-up

    After your surgery, you will be monitored for any signs of infection. This follow-up period lasts for 12 months.

    The main goal is to determine if the treatments used during surgery help reduce the need for reoperation due to infection.

  5. Step 5

    Completion of the study

    At the end of the 12-month follow-up, your participation in the study will be complete.

    The information collected will contribute to understanding the effectiveness of the treatments in preventing infections after TJR surgery.

Who can join the trial?

2 criteria

  • Patients must be 18 years of age or older.
  • Patients must be undergoing primary or aseptic revision TJR. TJR stands for Total Joint Replacement, which is a surgery to replace a joint, like a hip or knee, with an artificial one. Aseptic revision means replacing a joint that is not infected.

Who cannot join the trial?

3 criteria

  • Patients who are not adults cannot participate. This means you must be 18 years or older.
  • Patients who are not undergoing **TJR surgery** cannot participate. **TJR surgery** stands for Total Joint Replacement surgery, which is a procedure to replace a joint, like a hip or knee, with an artificial one.
  • Patients who are part of a vulnerable population cannot participate. This generally refers to groups who may have limited ability to give informed consent or are at higher risk of harm.
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Investigated drugs

  • Povidone-Iodine

    is a solution used to clean and disinfect the area around a surgical site. In this trial, it is being tested to see if it can reduce the risk of infection after hip or knee replacement surgery. The solution is used to wash out the surgical area during the procedure, and researchers want to find out if it helps prevent infections that might require another surgery within a year.

  • Chlorhexidine

    is another type of cleaning solution used during surgeries. It is being studied in this trial to determine if it can lower the chances of infection after hip or knee replacement surgery. Like the other solution, it is used to rinse the surgical area, and the goal is to see if it can help avoid infections that could lead to additional surgeries within a year.

  • Vancomycin

    is an antibiotic that is used to prevent infections. In this trial, it is applied directly to the surgical area during hip or knee replacement surgery. The study is looking at whether using vancomycin in this way can reduce the risk of infections that might require another surgery within a year.

What is already known about the treatment

  • Povidone-Iodine (PI) Irrigation Solution

    This medication is administered as an irrigation solution during surgery, specifically for patients undergoing total joint replacement (TJR). It is currently being studied to see if it can reduce the risk of infection-related reoperations within 12 months after surgery. The main therapeutic indication is infection prevention in surgical settings. At the molecular level, povidone-iodine works by releasing iodine, which kills bacteria and other pathogens. It is classified as an antiseptic.

  • Chlorhexidine Irrigation Solution

    This medication is used as an irrigation solution during surgery for patients undergoing total joint replacement (TJR). It is being evaluated for its effectiveness in reducing the risk of infection-related reoperations within 12 months post-surgery. The primary therapeutic use is to prevent infections during surgical procedures. Chlorhexidine works by disrupting the cell membranes of bacteria, leading to their death. It is classified as an antiseptic.

  • Vancomycin

    This medication is applied locally during surgery for patients undergoing total joint replacement (TJR). It is being tested to determine if it can lower the risk of infection-related reoperations within 12 months after surgery. The main therapeutic indication is infection prevention in surgical settings. Vancomycin works by inhibiting the synthesis of bacterial cell walls, which kills the bacteria. It is classified as an antibiotic.

Investigated diseases

Infection following Total Joint Replacement (TJR) – This condition occurs when bacteria or other pathogens invade the area around a joint prosthesis, such as a hip or knee, after surgery. The infection can develop soon after the surgery or even months later. It typically begins with localized symptoms like redness, swelling, and pain around the joint. As the infection progresses, it may lead to fever and drainage from the surgical site. If not addressed, the infection can spread to surrounding tissues and potentially enter the bloodstream. The progression of the infection can compromise the stability and function of the joint replacement.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515055-38-00Protocol codePiT-023Estimated enrolment24 096 patientsSponsorHamilton Health Sciences Corporation

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