Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone
Clinical Evaluation of the Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone
1 other identifier
interventional
936
1 country
3
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2022
CompletedFirst Posted
Study publicly available on registry
August 29, 2022
CompletedStudy Start
First participant enrolled
September 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
May 23, 2025
May 1, 2025
3.3 years
August 25, 2022
May 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
infection rate
Joint infection rate after surgery
at 90 days
Secondary Outcomes (1)
QT prolongation
up to 24 hours (from the time of irrigation to closure)
Study Arms (2)
The Next Science treatment
EXPERIMENTALThe surgical site will be irrigated with NS prior to closure, which will be suctioned at the end of the treatment time
Standard of Care
ACTIVE COMPARATORSaline irrigation
Interventions
The surgical site will be irrigated with NS prior to closure,
Eligibility Criteria
You may qualify 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
- 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)
- +8 more criteria
You may not qualify 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 dressings or any coverings)
- Subject has contraindications to general anesthesia
- Any subject positive for Covid-19 virus at time of surgical screening
- Subjects have evidence of prolonged QT segment, per EKG.
- Subjects from a vulnerable population, in accordance with 45 CFR 46 Subparts B, C, and D
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
- Next Science TMcollaborator
Study Sites (3)
North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Lenox Hill Hospital
New York, New York, 10075, United States
Related Publications (4)
Gronbeck C, Cote MP, Lieberman JR, Halawi MJ. Risk stratification in primary total joint arthroplasty: the current state of knowledge. Arthroplast Today. 2019 Feb 5;5(1):126-131. doi: 10.1016/j.artd.2018.10.002. eCollection 2019 Mar.
PMID: 31020036BACKGROUNDDoyle DJ, Goyal A, Bansal P, et al. American Society of Anesthesiologists Classification. [Updated 2020 Jul 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK441940/
BACKGROUNDMoonesinghe SR, Mythen MG, Das P, Rowan KM, Grocott MP. Risk stratification tools for predicting morbidity and mortality in adult patients undergoing major surgery: qualitative systematic review. Anesthesiology. 2013 Oct;119(4):959-81. doi: 10.1097/ALN.0b013e3182a4e94d.
PMID: 24195875BACKGROUNDBilimoria KY, Liu Y, Paruch JL, Zhou L, Kmiecik TE, Ko CY, Cohen ME. Development and evaluation of the universal ACS NSQIP surgical risk calculator: a decision aid and informed consent tool for patients and surgeons. J Am Coll Surg. 2013 Nov;217(5):833-42.e1-3. doi: 10.1016/j.jamcollsurg.2013.07.385. Epub 2013 Sep 18.
PMID: 24055383BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Giles Scuderi
Northwell Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Orthopaedic Surgery, Joint Reconstruction
Study Record Dates
First Submitted
August 25, 2022
First Posted
August 29, 2022
Study Start
September 26, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 23, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share