RecruitingNot ApplicableNCT05543941

Evaluating XPERIENCE™ Advanced Surgical Irrigation

Evaluating XPERIENCE™ Advanced Surgical Irrigation on Risk of Periprosthetic Joint Infection: A Multicenter Randomized Controlled Trial

Sponsor

Ottawa Hospital Research Institute

Enrollment

7,600 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

Knee Osteoarthritis hip osteoarthritis Hip Arthritis Knee arthritis

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Dilute Betadine and a medical device called XPERIENCE Advanced Surgical Irrigation for people with hip arthritis, knee osteoarthritis, and other related conditions. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEXPERIENCE 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.

DEVICEDilute 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.