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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunnybrook Health Sciences Centre

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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 design

Treatments tested in this trial

  • Chlorhexidne Gluconate-Alcohol Skin Preparation
  • Poviodine-iodine Skin Preparation

Treatment groups

400 Participants
are divided into 2 treatment groups