NCT05577936

Xperience™ vs Normal Saline Irrigation Solution for Decreasing Bioburden After Primary Total Hip and Knee Arthroplasty

A Randomized Controlled Trial of the Next Science® XPERIENCE™ Advanced Surgical Irrigation Versus Standard of Care Irrigation Efficacy in Decreasing Bioburden in Primary Total Hip and Knee Arthroplasty Wounds

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effectiveness of Xperience, a no rinse antimicrobial solution, on joint infection rates in patients undergoing total hip (THA) and total knee (TKA) arthoplasty surgery.

Conditions

• Total Knee Replacement Surgery
• Total Hip Replacement Surgery

Interventions

Type	Name	Description
DEVICE	XPERIENCE Advanced Surgical Irrigation	A clear, colorless, aqueous solution that is indicated for use in the cleansing and removal of debris, including microorganisms, from wounds. Soak for 3 minutes for a total volume of 1L
OTHER	Standard of Care Irrigation	17.5 mL povidone-iodine with 500 mL normal saline: solution (0.35%) for 3 minutes for a total volume of 1L (including a normal saline rinse)

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-10-13
• Last updated: 2023-04-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study