Health TrialsbyHealthPanel

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

ConditionsRevision Total Hip Arthroplasty (RTHA)Revision Total Knee Arthroplasty
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Chlorhexidne Gluconate-Alcohol Skin Preparation

    Procedure/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 Preparation

    Procedure/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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Chlorhexidine gluconate-alcohol solutionActive comparator 1 intervention
Group B: Povidone-iodine solutionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Assessment of accrual

Average number of patients enrolled per month: feasible if 10 or more overall

Time frame
2 years
2

Ability to deliver intervention the patient is randomized to receive

Feasible if \>90% of patients receive correct intervention

Time frame
2 years
3

Ability to collect complete data from participants

Feasible if \>80% of data is collected.

Time frame
2 years
4

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

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunnybrook Health Sciences Centre

Lead sponsor

Source ClinicalTrials.gov
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