A prospective, multi-center, double-arm, parallel, interventional, randomized, controlled clinical trial to assess the rate of periprosthetic joint infection (PJI) in patients undergoing primary total knee arthroplasty (TKA), total hip arthroplasty (THA) or hip resurfacing (HR) with XPERIENCE™ (XP) Advanced Surgical Irrigation versus dilute Betadine (DB).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
7,600
The patient will undergo THA, TKA, or HR with irrigation of the deep wound prior to fascial closure consisting of XPERIENCE Advanced Surgical Irrigation (XP). XP solution will be applied prior to fascial closure and left to soak for up to 3 minutes. Remaining product will be suctioned away throughout the procedure. No rinsing should take place after irrigation and surgical site will be closed according to site standard operating procedures.
The patient will undergo THA, HR or TKA with irrigation of the deep wound prior to fascial closure consisting of Dilute Betadine (DB). DB concentration will be standardized at 0.3% povidone-iodine. DB will be prepared by combining 30 mL of sterile 10% povidone-iodine (from a sterile catheter pack) with 1 L of 0.9% saline in a sterile splash basin. Solution will be left to soak for up to 3 minutes and remaining povidone-iodine solution will be suctioned away. Area will then be rinsed with 1L of normal saline. Surgical site will be closed according to site standard operating procedures.
University of British Columbia
Vancouver, British Columbia, Canada
NOT_YET_RECRUITINGLondon Health Sciences Center
London, Ontario, Canada
RECRUITINGThe Ottawa Hospital
Ottawa, Ontario, Canada
Rate of acute (<90 days post-surgery) PJI
Number of patients diagnosed with periprosthetic joint infection as per the diagnostic criteria outlined by the 2018 International Consensus Meeting of the Musculoskeletal Infection Society for Acute PJI.
Time frame: 2 weeks after surgery, 3 months after surgery, within 90 day of surgery
Rate of Superficial Wound Infections
Number of superficial wound infections
Time frame: 2 weeks after surgery
Rate of PJI at 1 year
Number of patients diagnosed with periprosthetic joint infections at 1 year after surgery
Time frame: 12 months after surgery
Subgroup analysis of PJI rates for high-risk patients
Number of patients diagnosed with PJI at 3 months and 1 year in higher risk patient categories (morbid obesity (BMI \>40kg/m2), diabetes mellitus, chronic kidney disease, inflammatory arthritis, active smokers (nicotine))
Time frame: 3 months after surgery, 12 months after surgery
Patient Reported Functional Outcome Scores
As measured by the Oxford Hip Score (OHS) or Oxford Knee Score (OKS)
Time frame: Before surgery, 3 months after surgery, 12 months after surgery
Patient Reported Quality of Life Scores
As measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: Before surgery, 3 months after surgery, 12 months after surgery
Wound Complications (non-infection) requiring revision surgery
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Humber River Health
Toronto, Ontario, Canada
NOT_YET_RECRUITINGSt. Joseph's Health Centre
Toronto, Ontario, Canada
RECRUITINGHôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
NOT_YET_RECRUITINGJewish General Hospital
Montreal, Quebec, Canada
NOT_YET_RECRUITINGMcGill University
Montreal, Quebec, Canada
NOT_YET_RECRUITINGCHU de Quebec-Université Laval
Québec, Quebec, Canada
NOT_YET_RECRUITINGNumber of patients requiring a revision surgery for a non-infection related wound complication
Time frame: 2 weeks after surgery