Total Knee Replacement SurgeryNCT05577936
Xperience™ vs Normal Saline Irrigation Solution for Decreasing Bioburden After Primary Total Hip and Knee Arthroplasty
A study testing XPERIENCE Advanced Surgical Irrigation in people with Total Knee Replacement Surgery and Total Hip Replacement Surgery, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Replacement Surgery, Total Hip Replacement Surgery
- What is being tested?
- XPERIENCE Advanced Surgical Irrigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- XPERIENCE Advanced Surgical Irrigation, Standard of Care Irrigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XPERIENCE Advanced Surgical IrrigationDevice
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
Standard of Care IrrigationOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Standard of Care Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in culture positive rates
Number of culture positive tissue samples
Measured: Baseline (pre-irrigation) and post-irrigation approximately 3 minutes
Secondary outcomes (1)
Deep Periprosthetic Joint Infection
Number of subjects to have deep periprosthetic joint infection within 90 days of index operation
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study startMar 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Delay in funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Replacement SurgeryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cameron K. Ledford, Mayo Clinic
- Investigators
- Cameron Ledford, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577936
- Sponsor's protocol ID
- 21-004244
- Status last verified
- Apr 2023
- First submitted
- 9 Oct 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05577936
- Acronym / sponsor ID
- 21-004244
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Delay in funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xperience no rinse antimicrobial solution group | Experimental | Device: XPERIENCE Advanced Surgical IrrigationXPERIENCE Advanced Surgical Irrigation will be utilized as the final wash after the TKA or THA procedure prior to closure |
| Normal saline solution group | Active comparator | Other: Standard of Care IrrigationStandard of care irrigation will be utilized as the final wash after the TKA or THA procedure prior to closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XPERIENCE Advanced Surgical IrrigationA 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 | Device | Xperience no rinse antimicrobial solution group |
| Standard of Care Irrigation17.5 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) | Other | Normal saline solution group |
Primary outcome
Change in culture positive rates
Time frame: Baseline (pre-irrigation) and post-irrigation approximately 3 minutes
Number of culture positive tissue samples
1 secondary outcome
Deep Periprosthetic Joint Infection
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Total Knee Replacement Surgery
RecruitingPhase 3
Suzetrigine in TKA
Total Knee Arthroplasty (TKA), Total Knee Arthroplasty \(TKA\)
RecruitingPhase 3
Suzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN
Total Knee Replacement Surgery, Post-operative Pain
Recruiting
Cold and Compression Post TKA
Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery
Recruiting
Mako Cementless TKA vs Mako Cemented TKA
Total Knee Replacement, Total Knee Replacement Surgery
Active, not recruitingPhase 4
Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine in Spinal Anaesthesia
Knee Replacement, Total, Knee Replacement Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cameron Ledford, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XPERIENCE Advanced Surgical Irrigation in people with Total Knee Replacement Surgery and Total Hip Replacement Surgery, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in culture positive rates (time frame: Baseline (pre-irrigation) and post-irrigation approximately 3 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023; AzTrials last refreshed its copy on 31 Oct 2026.