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

NCT05577936 | Withdrawn DMC FDA Device

• 1 other identifier: 21-004244
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in culture positive rates

  Number of culture positive tissue samples

  Baseline (pre-irrigation) and post-irrigation approximately 3 minutes

Secondary Outcomes (1)

• Deep Periprosthetic Joint Infection

  90 days

Study Arms (2)

Xperience no rinse antimicrobial solution group

EXPERIMENTAL

XPERIENCE Advanced Surgical Irrigation will be utilized as the final wash after the TKA or THA procedure prior to closure

Device: XPERIENCE Advanced Surgical Irrigation

Normal saline solution group

ACTIVE COMPARATOR

Standard of care irrigation will be utilized as the final wash after the TKA or THA procedure prior to closure.

Other: Standard of Care Irrigation

Interventions

XPERIENCE Advanced Surgical Irrigation DEVICE

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

Xperience no rinse antimicrobial solution group

Standard of Care Irrigation OTHER

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)

Normal saline solution group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to undergo primary total hip (via direct anterior approach, press-fit components) or total knee arthroplasty (via manual approach, cemented components).
• Willing to comply with all study-related procedures and be available for the duration of the study.
• Provide signed and dated informed consent.

You may not qualify if:

• Unable to provide signed and dated informed consent.
• Unwilling or unable to comply with all study-related procedures.
• Known history of sensitivity or allergic reaction to any of the study products or its components, including any products used for standard of care (such as dressings or any coverings).
• Has underlying condition or state that, in the 'investigator's opinion, would make them too critically ill to complete the day 90 postoperative follow ups.
• Pregnant, planning to become pregnant, or nursing female subjects.
• Subject with any mental impairment or condition that would make them unable to properly consent without use of LAR or additional subject protections.
• Subject is a prisoner and/or part of a vulnerable subject population, which necessitates additional human research subject protections beyond the scope of this protocol.
• Subject with an active infection or systemic antibiotic therapy within 2 weeks prior to surgery with the exception of preoperative antimicrobial prophylaxis.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Cameron Ledford, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2022
• First Posted: October 13, 2022
• Study Start: March 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)