Evaluating XPERIENCE™ Advanced Surgical Irrigation
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: XPERIENCE Advanced Surgical Irrigation Patients will receive the XPERIENCE Advanced Surgical Irrigation prior to wound closure. |
Device: XPERIENCE Advanced Surgical Irrigation
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.
Other Names:
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| Active Comparator: Dilute Betadine Patients will receive Dilute Betadine solution prior to wound closure. |
Device: Dilute Betadine
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Rate of acute (<90 days post-surgery) PJI [2 weeks after surgery, 3 months after surgery, within 90 day of surgery]
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.
Secondary Outcome Measures
- Rate of Superficial Wound Infections [2 weeks after surgery]
Number of superficial wound infections
- Rate of PJI at 1 year [12 months after surgery]
Number of patients diagnosed with periprosthetic joint infections at 1 year after surgery
- Subgroup analysis of PJI rates for high-risk patients [3 months after surgery, 12 months after surgery]
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))
- Patient Reported Functional Outcome Scores [Before surgery, 3 months after surgery, 12 months after surgery]
As measured by the Oxford Hip Score (OHS) or Oxford Knee Score (OKS)
- Patient Reported Quality of Life Scores [Before surgery, 3 months after surgery, 12 months after surgery]
As measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
- Wound Complications (non-infection) requiring revision surgery [2 weeks after surgery]
Number of patients requiring a revision surgery for a non-infection related wound complication
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and female patients aged 18 years or older
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Diagnosis of osteoarthritis, inflammatory arthritis, osteonecrosis, or post-traumatic arthritis to the affected joint.
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Primary TKA, THA, and HR
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Subjects receiving both cemented or uncemented orthopaedic implants
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Willing and able to sign written consent, follow study protocol and attend follow-up
Exclusion Criteria:
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Inability or refusal to sign informed consent form
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Non-English or French speaking, and no licensed translator, family member or substitute decision maker available.
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Prior arthroplasty procedure to the affected joint
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Procedures involving solid HA implants
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Oncologic diagnosis to the affected joint.
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Non-TKA, THA or HR prosthesis (i.e., hemiarthroplasty, unicompartmental arthroplasty etc.)
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Allergy to any of the components of XP Advanced Surgical Irrigation
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Allergy to iodine
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Chronic Immunosuppression (i.e. history of human immunodeficiency virus, treatment with immunosuppressive agent for cancer, solid organ transplant).
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History of septic arthritis to the affected joint within two years of surgery(1).
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History of steroid injection to the affected joint within the three months preceding surgery.
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Simultaneous bilateral total joint arthroplasty
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Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
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Subjects with evidence of prolonged QT segment, per screening EKG.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ottawa Hospital Research Institute
- Next Science TM
Investigators
- Principal Investigator: Simon Garceau, MD, The Ottawa Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ISR-0104