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Antiseptic Solution

Antiseptic Skin Preparation for Joint Replacement Surgery (CLEANJoint Trial)

Phase 4

Recruiting

Led By Raman Mundi, D MSc FRCSC

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled to undergo aseptic revision total hip arthroplasty or total knee arthroplasty with exchange of at least one prosthetic component

Aged 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years from the start of the study

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial aims to compare two types of solutions that help remove harmful bacteria on the skin during surgery. The main goal is to see if these solutions can reduce the need for additional surgery or infections within a

Who is the study for?

This trial is for adults aged 18 or older who are scheduled to have revision surgery on a hip or knee replacement where at least one artificial joint part will be swapped out. It's not suitable for those with conditions that might interfere with the study.

What is being tested?

The study compares two antiseptic solutions used during surgery: chlorhexidine gluconate-alcohol and povidone-iodine, to see which is better at preventing infections after hip or knee replacement revisions. Participants will be randomly assigned to a solution and surveyed twice post-surgery.

What are the potential side effects?

Potential side effects may include skin reactions like irritation, redness, or rash from either chlorhexidine gluconate-alcohol or povidone-iodine solutions applied during surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a hip or knee replacement revision.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years from the start of the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years from the start of the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years from the start of the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

4. To estimate the incidence of reoperation for wound complication or PJI at one year

Ability to collect complete data from participants

Ability to deliver intervention the patient is randomized to receive

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Active Control

Group I: Chlorhexidine gluconate-alcohol solutionActive Control1 Intervention

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.

Group II: Povidone-iodine solutionActive Control1 Intervention

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.

0 / 2Eligibility criteria met