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 skin preparation solutions (chlorhexidine gluconate-alcohol solution and povidone-iodine solution) that help eliminate harmful bacteria on the skin at the time of surgery for patients having revision arthroplasty surgery of the hip or knee.

The main outcome of interest for the definitive study is the need for re-operation for a wound complication or an infection of the prosthetic joint within one year after surgery.

For the pilot trial, our main interest is to determine feasibility of a definitive trial. Feasibility outcomes will include: ability to recruit patients, ability to randomize patients, ability to collect complete data, estimate the event rate of our primary outcome, ability to carry out data linkages and determine the accuracy of collected data.

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

Study Overview

• Status: Recruiting
• Conditions: Revision Total Knee Arthroplasty; Revision Total Hip Arthroplasty (RTHA)
• Intervention / Treatment: Procedure: Chlorhexidne Gluconate-Alcohol Skin Preparation; Procedure: Poviodine-iodine Skin Preparation

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin Lillie, MSc; Phone Number: (437) 227-4458; Email: CLEANJoint@sunnybrook.ca

Study Locations

• Canada
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Active, not recruiting
      • Royal Victoria Regional Health Centre
    • Greater Sudbury, Ontario, Canada, P3E 5J1
      • Recruiting
      • Health Sciences North
      • Contact: Ryan Hodgins, MD FRCSC; Phone Number: (705) 522-9101; Email: rhodgins@hsnsudbury.ca
      • Principal Investigator: Ryan Hodgins, MD FRCSC
    • Toronto, Ontario, Canada, M4Y 1H1
      • Active, not recruiting
      • Sunnybrook Holland Centre

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.	Procedure: Chlorhexidne Gluconate-Alcohol Skin Preparation; Participants will undergo skin antisepsis with 4% chlorhexidine gluconate pre-wash, followed by 2% chlorhexidine gluconate with 70% isopropyl alcohol skin preparation. The surgical field to be sterilized will be at the discretion of the surgical team, but typically includes the distal torso to ankle for patients undergoing hip arthroplasty and proximal thigh to ankle for patients undergoing knee arthroplasty. Pre-wash of the surgical area will be carried out using a wet chlorhexidine surgical scrub brush followed by immediate drying using towels. The definitive preparation will then be carried out using tinted chlorhexidine gluconate-alcohol sponges applied with forceps. The drying time and the minimum number of sponge packs used will comply with the product 'Instructions for Use'. The drapes can be applied as per the surgeon's usual approach and they will be treated according to the institution and surgeon's routine practice for draping and surgical site infection prevention.
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.	Procedure: Poviodine-iodine Skin Preparation; Participants will undergo skin antisepsis with 7.5% povidone-iodine detergent pre-wash, followed by 10% povidone-iodine skin preparation. The surgical field to be sterilized will be at the discretion of the surgical team, but typically includes the distal torso to ankle for patients undergoing hip arthroplasty and proximal thigh to ankle for patients undergoing knee arthroplasty. Pre-wash of the surgical area will be carried out using iodine detergent soaked gauze pads followed by immediate drying using towels. The definitive preparation will then be carried out using povidone-iodine soaked gauze pads applied with forceps. The drapes can be applied as per the surgical team's usual approach and they otherwise will be treated according to the institution and surgeon's routine practice for draping and surgical site infection prevention.

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 overall	2 years
Ability to deliver intervention the patient is randomized to receive	Feasible if >90% of patients receive correct intervention	2 years
Ability to collect complete data from participants	Feasible if >80% of data is collected.	2 years
To estimate the aggregate incidence of reoperation for wound complication or PJI at one year	Number of reoperations for wound complication or PJI within one year in each group	2 years
Ability to link collected outcome data with ICES datasets	Feasible if linkage is possible in >90% of participants.	2 years
Validation of the accuracy of outcome data collected through registries and surveillance programs	a) Valid if >90% agreement (sensitivity, specificity, positive predictive value, negative predictive value) for each outcome (collected at follow-up).	2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

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): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: prosthetic joint infection; PJI; registry-based RCT
• Additional Relevant MeSH Terms: Organic Chemicals; Alcohols; Ethanol
• Other Study ID Numbers: 4000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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