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

CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee - A Vanguard Randomized Controlled Registry Trial (CLEAN Joint Trial)

The goal of this clinical trial is to compare two types of solutions (chlorhexidine gluconate-alcohol solution or povidone-iodine solution) that help eliminate harmful bacteria on the skin at the time of surgery.

The main outcome of interest is:

• the need for re-operation for a wound complication or an infection of the prosthetic joint within one year after surgery.

Participants will be contacted at two time points after surgery to complete a 5-minute survey: after 30 days, and after 1 year.

If you decide to participate, you will be randomly assigned (like flipping a coin) by a computer, to one of the possible interventions. You will be told which group you have been assigned to.

Study Overview

• Status: Recruiting
• Conditions: Aseptic Revision Total Hip Arthroplasty; Total Knee Arthroplasty With Exchange of at Least One Prosthetic Component
• Intervention / Treatment: Drug: surgical antiseptic skin preparation with either chlorhexidine or iodine-based solution

Detailed Description

In this trial, participants will be assigned randomly to have their surgical skin site prepared for surgery with either chlorhexidine gluconate-alcohol solution or povidone-iodine solution. These are two types of solutions that have antiseptic properties, which means they help eliminate harmful bacteria on the skin at the time of surgery, and therefore, reduce the risk of infection. Surgeons routinely use either chlorhexidine-based or iodine-based skin preparation solutions at the time of surgery to sterilize the surgical area. However, we don't know which one works best for patients having revision joint replacement surgery. There is a small chance of having an allergic reaction to the chlorhexidine or iodine, but there is no additional risk by participating in this study, as these skin preparation solutions are routinely used in practice.

The main outcome of interest is the need for re-operation for a wound complication or an infection of the prosthetic joint within one year after surgery. Other key outcomes are surgical site infection, mortality, and readmission to hospital. Participants will be contacted 30 days after surgery to complete a survey online, by phone, or in person, which will take approximately 5 minutes to complete. All other outcome data will be collected by phone call, health records, routine hospital monitoring, or electronic registry data at thirty days and one year after surgery.

You may choose to participate in this trial, or not. If you decide to participate, you will be randomly assigned (like flipping a coin) by a computer, to one of the possible interventions. You will be told which group you have been assigned to. Participating in this program is your choice (i.e., is voluntary). You have the right to choose not to participate, or to stop participating in this program at any time. Your decision will not affect the care you receive at this time, or in the future. As part of this program, we will use data that is already routinely collected from your hospital stay for administrative and quality-improvement purposes. We will collect your OHIP number to securely link the records we collect to other databases already collected. We will also collect your first and last name, email address and phone number, for follow-up survey purposes. The person conducting this study and other study staff will keep the information they see or receive about you confidential. Your de-identified study information will be kept in a secure and confidential location and then destroyed according to institutional policy. You will not be paid for taking part in this study and there will be no costs associated with participation. If you agree to take part, there may or may not be any direct benefit to you. You will receive a Research Study Information Sheet for your reference. The Research Ethics Board that oversees the ethical conduct of this study may review your relevant study records for audit purposes.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Raman Mundi, MD MSc FRCSC; Phone Number: 416-967-8778; Email: raman.mundi@sunnybrook.ca
• Study Contact Backup: Name: Erin Lillie; Phone Number: (437) 227-4458; Email: erin.lillie@sunnybrook.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • SunnyBrook Health Sciences Centre
      • Contact: Erin Lillie; Phone Number: (437) 227-4458; Email: erin.lillie@sunnybrook.ca
      • Contact: Stephanie Lewaniak; Phone Number: 45656 (416) 967-8500; Email: stephanie.lewaniak@sunnybrook.ca
      • Principal Investigator: Raman Mundi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18 years or older
2. Scheduled to undergo aseptic revision total hip arthroplasty or total knee arthroplasty with exchange of at least one prosthetic component

Exclusion Criteria:

1. Revision for prosthetic joint infection or wound complication
2. Known history of previous prosthetic joint infection in the operative joint
3. Any degree of clinical concern for prosthetic joint infection
4. History of allergy to iodine, chlorhexidine, or alcohol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chlorhexidine gluconate-alcohol solution; 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.	Drug: surgical antiseptic skin preparation with either chlorhexidine or iodine-based solution; Patients will be randomized to receive surgical antiseptic skin preparation with either chlorhexidine or iodine-based solution. Specifically, the first treatment arm will undergo skin antisepsis with 4% chlorhexidine gluconate pre-wash, followed by 2% chlorhexidine gluconate with 70% isopropyl alcohol skin preparation. The second treatment arm will undergo skin antisepsis with 7.5% povidone-iodine detergent pre-wash, followed by 10% povidone-iodine skin preparation.
Active Comparator: Povidone-iodine solution; 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.	Drug: surgical antiseptic skin preparation with either chlorhexidine or iodine-based solution; Patients will be randomized to receive surgical antiseptic skin preparation with either chlorhexidine or iodine-based solution. Specifically, the first treatment arm will undergo skin antisepsis with 4% chlorhexidine gluconate pre-wash, followed by 2% chlorhexidine gluconate with 70% isopropyl alcohol skin preparation. The second treatment arm will undergo skin antisepsis with 7.5% povidone-iodine detergent pre-wash, followed by 10% povidone-iodine skin preparation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of accrual	Average number of patients enrolled per month: feasible if 10 or more on average	2 years from the start of the study
Ability to deliver intervention the patient is randomized to receive	Feasible if >90% of patients receive correct intervention	2 years from the start of the study
Ability to collect complete data from participants:	Feasible if >80% of data is collected.	2 years from the start of the study
4. To estimate the incidence of reoperation for wound complication or PJI at one year	a) Number of reoperations for wound complication or PJI within one year in each group	2 years from the start of the study
Ability to link collected outcome data with ICES datasets	Feasible if linkage is possible in >90% of participants	2 years from the start of the study
Validation of the accuracy of outcome data collected through ICES	a) Valid if >90% agreement (sensitivity, specificity, positive predictive value, negative predictive value) for each outcome (collected at follow-up)	2 years from the start of the study

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Raman Mundi, D MSc FRCSC, SunnyBrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Disinfectants; Chlorhexidine; Anti-Infective Agents, Local
• Other Study ID Numbers: 4000

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No