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Antiseptic Solution

Chlorhexidine gluconate-alcohol solution for Total Knee Replacement (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

CLEANJoint Trial 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.Check my eligibility

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.See study design

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.

CLEANJoint Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am scheduled for a hip or knee replacement revision.

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I am 18 years old or older.

CLEANJoint Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

CLEANJoint 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

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,187 Total Patients Enrolled

Raman Mundi, D MSc FRCSCPrincipal InvestigatorSunnybrook Health Sciences Centre

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients to participate in this clinical trial?

"According to the latest information provided by clinicaltrials.gov, this trial is currently enrolling participants. The trial was initially posted on May 18th, 2023 and underwent its last update on January 22nd, 2024."

Answered by AI

What is the overall count of participants enrolled in this research endeavor?

"Indeed, the information provided on clinicaltrials.gov indicates that this trial is currently in the process of recruiting participants. The study was initially posted on May 18th, 2023 and underwent its last revision on January 22nd, 2024. A total of 120 patients will be enrolled from a single site."

Answered by AI

What are the potential risks and hazards associated with using Chlorhexidine gluconate-alcohol solution in individuals?

"Chlorhexidine gluconate-alcohol solution has been deemed safe with a rating of 3 by our team at Power. This is based on the fact that it is undergoing a Phase 4 trial, indicating that this treatment has already received approval."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05828810.

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