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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Infanta Leonor	Madrid	Spain
Consorci Sanitari De Terrassa	Terrassa	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Principe De Asturias	Alcala De Henares	Spain
Parc Sanitari Sant Joan De Deu	Sant Boi De Llobregat	Spain
Fundacio Assistencial De Mutua De Terrassa Fpc	Terrassa	Spain
Consorci Sanitari De L’Alt Penedes I Garraf	Vilafranca Del Penedes	Spain
Hospital San Juan De Dios Santurtzi	Santurtzi	Spain
Fttbdgryx Pmvd Le Iyxqmljynmcfy Beooguihb Diy Hmbpagny Uibmcvntkevis Lm Pgg	Madrid	Spain
Hiheqspc Vcio dhwoqaqv	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	16.09.2024

Trial locations

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.

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 ID:

2024-515055-38-00

Protocol code:

PiT-023

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?