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Compares treatment options for Joint Infection
Official title Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone
ClinicalTrials.gov ID: NCT05519007
What this study is testing
- What it's testing
- A prospective, single-site, double-arm, parallel, interventional, randomized, controlled clinical trial to assess 90-day rate of joint infections in subjects undergoing primary hip replacements after administration of Next Science No-Rinse Solution (hereby referred to as NS) vs SOC (saline irrigation). The Next Science treatment arm will exhibit greater reduction in rate of 90-day post-operative joint infection than SOC (saline) arm
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults. Healthy volunteers may be eligible.
You may be able to join if
- Adult that meets at least one of the below criteria at time of screening:
- American Society of Anesthesiologists (ASA) 3 2
- BMI \>35
- Patient with functional limitations as a result of disease1:
- Poorly treated hypertension
You likely can't join if
- Unable to provide signed and dated informed consent.
- Unable or unwilling to comply with all study-related procedures.
- Known history of allergic reaction to any of the study products or its components, including any products used for standard of care (such as...
- Subject has contraindications to general anesthesia
- Any subject positive for Covid-19 virus at time of surgical screening
- people have evidence of prolonged QT segment, per EKG.
See the full eligibility criteria
- Adult that meets at least one of the below criteria at time of screening:
- American Society of Anesthesiologists (ASA) 3 2
- BMI \>35
- Patient with functional limitations as a result of disease1:
- Poorly treated hypertension
- Poorly treated diabetes
- Chronic renal failure
- Bronchospastic disease
- Disease with intermittent exacerbations
- Stable angina
- Implanted pacemaker
- Known history as an active nicotine use (smoker)
- Known history of uncontrolled diabetes mellitus (HgbA1C \> 7.0)
- Known history of end stage organ disease
- Known history of inflammatory arthritis and currently on rheumatological medication (DMARDs)
- Known history of current active cancer treatment (chemotherapy)
- Venous Disease (Surgical Risk Calculator from ACS-NSQIP)
- Charleston Comorbidity Score \> 2
- Elixhauser Score \>11
- Age 65 or older
- Subject is scheduled to primary joint replacement.
- Subject is willing and able to comply with all study procedures including transportation to the study site for all scheduled visits and be available for the duration of the study.
- Subject has understood, signed, and dated the informed consent form.
- Unable to provide signed and dated informed consent.
- Unable or unwilling to comply with all study-related procedures.
- Known history of 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)
- Subject has contraindications to general anesthesia
- Any subject positive for Covid-19 virus at time of surgical screening
- people have evidence of prolonged QT segment, per EKG.
- people from a vulnerable population, in accordance with 45 CFR 46 Subparts B, C, and D
The study team makes the final eligibility decision.
Where it's taking place
- Manhasset, New York, United States
- New Hyde Park, New York, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Manhasset, New York, United States; New Hyde Park, New York, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.