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

April 22, 2026 updated by: Sunnybrook Health Sciences Centre

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:
        • Principal Investigator:
          • Ryan Hodgins, MD FRCSC
      • Toronto, Ontario, Canada, M4Y 1H1
        • Active, not recruiting
        • Sunnybrook Holland Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of accrual
Time Frame: 2 years
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
Time Frame: 2 years
Feasible if >90% of patients receive correct intervention
2 years
Ability to collect complete data from participants
Time Frame: 2 years
Feasible if >80% of data is collected.
2 years
To estimate the aggregate incidence of reoperation for wound complication or PJI at one year
Time Frame: 2 years
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
Time Frame: 2 years
Feasible if linkage is possible in >90% of participants.
2 years
Validation of the accuracy of outcome data collected through registries and surveillance programs
Time Frame: 2 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunnybrook Health Sciences Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raman Mundi, MD MSc FRCSC, Sunnybrook Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 25, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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