RecruitingNAINTERVENTIONAL

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

This study looks at two types of skin cleaners – chlorhexidine-alcohol and povidone-iodine – that surgeons use to clean your skin before hip or knee replacement revision surgery. The main goal is to find out which cleaner is more effective at preventing problems like infections or other wound complications that might lead to another operation within a year. Doctors already use both cleaners regularly, but we don't know which one works best for these specific types of revision surgeries. You would be asked to complete two short surveys after your surgery, after 30 days and again after one year. This research helps improve care for patients needing joint revision surgery.

At a glance

Status

Recruiting

Phase

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

400

Start

25 Jul 2023

Estimated completion

01 Nov 2026

Revision Total Hip Arthroplasty (RTHA)Revision Total Knee Arthroplasty

What is this study about?

When you have an operation, especially a joint replacement revision in your hip or knee, keeping the area free from germs is incredibly important. Before surgery, doctors always clean the skin thoroughly to lower the risk of infection. They typically use special liquids that kill germs, known as antiseptics. This study is looking at two common antiseptic skin cleaners: one called chlorhexidine-alcohol and another called povidone-iodine.

Both of these cleaners are regularly used in hospitals. Doctors want to find out if one of them is better than the other at preventing serious problems after revision surgery. These problems could include infections around the new joint or complications with the wound that might need another operation within a year. By comparing these two cleaners, the study hopes to improve the way future revision surgeries are done, making them safer for patients.

Taking part in this study means you would be randomly assigned to receive one of these two-skin cleaners before your surgery. This is like flipping a coin to decide, making sure the comparison is fair. Apart from which cleaner is used, your surgery and care will be the same as usual. The researchers will then carefully follow your progress for up to a year to see if you have any complications, particularly infections or issues that require further surgery.

Key takeaways

Compares two common skin cleaners (chlorhexidine-alcohol vs. povidone-iodine) for hip/knee revision surgery.
Aims to find out which cleaner is better at preventing infections and complications.
Participation involves no extra tests or hospital visits, just your usual surgery and care.
You'll complete two short surveys (5 minutes each) after 30 days and 1 year.
No extra risks compared to standard surgery, as both cleaners are routinely used.
Helps improve safety and results for future patients having similar surgeries.

Who may be eligible?

To join this study, you need to be 18 years old or older. You must also be scheduled to have a revision (redo) total hip or total knee replacement surgery. This means you've had a joint replacement before, and now you're having part or all of it replaced again for reasons other than infection.

You cannot join the study if your revision surgery is specifically because of an infection in your joint or a wound problem. Also, if there's any concern that your joint might be infected, or if you've had a known infection in that same joint before, you wouldn't be able to take part. Finally, if you know you're allergic to iodine, chlorhexidine, or alcohol, which are ingredients in the skin cleaners used, you should not be in this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having a revision total hip or total knee replacement surgery?
Is your revision surgery NOT because of an existing infection or wound problem?
Have you ever had an allergy to iodine, chlorhexidine, or alcohol?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't need any extra hospital visits or assessments beyond your usual care. During your scheduled hip or knee revision surgery, the medical team will clean your skin with either the chlorhexidine-alcohol solution or the povidone-iodine solution as part of their standard procedure. You won't have to take any special medication for the study.

After your surgery, we will ask you to complete two very short surveys, each taking about 5 minutes. The first survey will be about 30 days after your operation, and the second will be a year after. You can complete these surveys online, over the phone, or in person, whichever is easiest for you. The total duration of your participation in the study from start to finish would be one year after your surgery. Researchers will also collect other information about your recovery and progress from your usual hospital records.

Potential risks and benefits

There are no additional risks to taking part in this study, as both skin cleaners are routinely used in all hospitals for surgery. There's a very small chance of having an allergic reaction to either solution, but this is a known, rare risk whenever they are used. By participating, you could help doctors understand which skin cleaner is most effective at preventing infections and complications after revision joint surgery, potentially improving care for future patients. You are free to withdraw from the study at any time without affecting your medical care.

Locations (3)

Royal Victoria Regional Health Centre
Verified postcode
Barrie, Canada· Active not recruiting
Health Sciences North
Verified postcode
Greater Sudbury, Canada· Recruiting
Sunnybrook Holland Centre
Verified postcode
Toronto, Canada· Active not recruiting

Common questions

What is 'revision' joint surgery?

Revision joint surgery means replacing part or all of a previous hip or knee replacement. It's like having a 'redo' of an earlier operation.

What are antiseptics?

Antiseptics are special liquids, like the skin cleaners used before your operation, that kill germs on your skin to help prevent infections.

Will I know which skin cleaner I received?

No, you will be assigned to one of the cleaners by chance, and neither you nor your surgeon will know which one you received to keep the study fair. This is called 'randomisation'.

Do I have to do anything differently for this study?

Apart from completing two short surveys after your surgery, you won't need to do anything else differently. Your surgery and follow-up care will be as normal.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and this will not affect the quality of your medical care.

How to find out more

Erin Lillie, MSc

cleanjoint@sunnybrook.ca (437) 227-4458 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.