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

Total Knee Replacement Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05577936
• Other study ID #: 21-004244
• Status: Withdrawn
• Phase: N/A
• Start date: March 2023
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Total Hip Replacement Surgery
• Total Knee Replacement Surgery

Intervention

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)

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in culture positive rates	Number of culture positive tissue samples	Baseline (pre-irrigation) and post-irrigation approximately 3 minutes
Secondary	Deep Periprosthetic Joint Infection	Number of subjects to have deep periprosthetic joint infection within 90 days of index operation	90 days

External Links

•   Mayo Clinic Clinical Trials