Revision Total Hip Arthroplasty (RTHA)CLEANJointNCT05828810

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

A study testing Chlorhexidne Gluconate-Alcohol Skin Preparation and Poviodine-iodine Skin Preparation in people with Revision Total Hip Arthroplasty (RTHA) and Revision Total Knee Arthroplasty, run by Sunnybrook Health Sciences Centre at 3 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Revision Total Hip Arthroplasty (RTHA), Revision Total Knee Arthroplasty
What is being tested?: Chlorhexidne Gluconate-Alcohol Skin Preparation and Poviodine-iodine Skin Preparation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 3 sitesCanada
Study dates: 25 Jul 2023to Nov 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2
Health Sciences North
Greater Sudbury, Ontario, P3E 5J1
Sunnybrook Holland Centre
Toronto, Ontario, M4Y 1H1

Other trials in Canada

About this study

Official title: 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 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.

Read the 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.

Conditions: Revision Total Hip Arthroplasty (RTHA), Revision Total Knee Arthroplasty
Being tested: Chlorhexidne Gluconate-Alcohol Skin Preparation, Poviodine-iodine Skin Preparation
Keywords: prosthetic joint infection, registry-based RCT, PJI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chlorhexidne Gluconate-Alcohol Skin PreparationProcedure or surgery
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.
Poviodine-iodine Skin PreparationProcedure or surgery
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.

Study groups in NCT05828810
Study group	Role	What they receive
Chlorhexidine gluconate-alcohol solution	Active comparator	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. Receives: Procedure: Chlorhexidne Gluconate-Alcohol Skin Preparation
Povidone-iodine solution	Active comparator	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. Receives: Procedure: Poviodine-iodine Skin Preparation

What is being measured

The primary outcome is the main question the study is designed to answer.

Assessment of accrual
Average number of patients enrolled per month: feasible if 10 or more overall
Measured: 2 years
Ability to deliver intervention the patient is randomized to receive
Feasible if >90% of patients receive correct intervention
Measured: 2 years
Ability to collect complete data from participants
Feasible if >80% of data is collected.
Measured: 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
Measured: 2 years
Ability to link collected outcome data with ICES datasets
Feasible if linkage is possible in >90% of participants.
Measured: 2 years
Validation of the accuracy of outcome data collected through registries and surveillance programs
1. Valid if >90% agreement (sensitivity, specificity, positive predictive value, negative predictive value) for each outcome (collected at follow-up).
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jul 2023Nov 2026

First posted25 Apr 2023
Study start25 Jul 2023
Primary completionNov 2026 (estimated)
Study completionNov 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Revision Total Hip Arthroplasty (RTHA)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a multicentre, pragmatic, open label, 2-arm parallel-group Vanguard feasibility RCT.
Masking: None (open label)
Enrolment: 400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05828810
Sponsor's protocol ID: 4000
Acronym: CLEANJoint
Status last verified: Sep 2026
First submitted: 12 Apr 2023
Last updated: 8 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No