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

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)

Overview

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.

Interventions

• 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
• 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 dr

Primary outcome measures

• Assessment of accrual [Time frame: 2 years]
• Ability to deliver intervention the patient is randomized to receive [Time frame: 2 years]
• Ability to collect complete data from participants [Time frame: 2 years]
• To estimate the aggregate incidence of reoperation for wound complication or PJI at one year [Time frame: 2 years]
• Ability to link collected outcome data with ICES datasets [Time frame: 2 years]
• Validation of the accuracy of outcome data collected through registries and surveillance programs [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Canada · 3 centers

• Royal Victoria Regional Health Centre — Barrie
• Health Sciences North — Greater Sudbury
• Sunnybrook Holland Centre — Toronto

Identifiers

NCT: NCT05828810 · 4000

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗