Trials / Recruiting
RecruitingNCT05543941
Evaluating XPERIENCE™ Advanced Surgical Irrigation
Evaluating XPERIENCE™ Advanced Surgical Irrigation on Risk of Periprosthetic Joint Infection: A Multicenter Randomized Controlled Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 7,600 (estimated)
- Sponsor
- Ottawa Hospital Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-04-01
- Primary completion
- 2027-03-31
- Completion
- 2027-12-31
- First posted
- 2022-09-16
- Last updated
- 2025-08-13
Locations
9 sites across 1 country: Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05543941. Inclusion in this directory is not an endorsement.