Revision Total Hip Arthroplasty (RTHA), Revision Total Knee Arthroplasty
Conditions
Keywords
prosthetic joint infection, registry-based RCT, PJI
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.
Interventions
PROCEDUREChlorhexidne 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.
PROCEDUREPoviodine-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.
Sponsors
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Data analysts will be blinded
Intervention model description
This is a multicentre, pragmatic, open label, 2-arm parallel-group Vanguard feasibility RCT.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Canada
Contacts
CONTACTErin Lillie, MSc
PRINCIPAL_INVESTIGATORRaman Mundi, MD MSc FRCSC
Sunnybrook Health Sciences Centre
Outcome results
None listed