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RECRUITING
NCT05543941
NA

Evaluating XPERIENCE™ Advanced Surgical Irrigation

Sponsor: Ottawa Hospital Research Institute

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

7600

Start Date

2023-04-01

Completion Date

2027-12-31

Last Updated

2025-08-13

Healthy Volunteers

No

Interventions

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.

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.

Locations (9)

University of British Columbia

Vancouver, British Columbia, Canada

London Health Sciences Center

London, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Humber River Health

Toronto, Ontario, Canada

St. Joseph's Health Centre

Toronto, Ontario, Canada

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

McGill University

Montreal, Quebec, Canada

CHU de Quebec-Université Laval

Québec, Quebec, Canada