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

Not Applicable

Recruiting

• Conditions: Revision Total Hip Arthroplasty (RTHA); Revision Total Knee Arthroplasty
• Interventions: Drug: surgical antiseptic skin preparation with either chlorhexidine or iodine-based solution

• Registration Number: NCT05828810
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief 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.

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.

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 Timeline

• Study First Submitted: 2023-04-12
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-25
• Study Start: 2023-07-25
• Status Verified: 2024-07
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-07
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine gluconate-alcohol solution	surgical antiseptic skin preparation with either chlorhexidine or iodine-based 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.
Povidone-iodine solution	surgical antiseptic skin preparation with either chlorhexidine or iodine-based 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.

Primary Outcome Measures

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

Trial Locations

Locations (3)

Royal Victoria Regional Health Centre; 🇨🇦 Barrie, Ontario, Canada

Sunnybrook Holland Centre; 🇨🇦 Toronto, Ontario, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada