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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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 sites (3)

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