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| Name | Class |
|---|---|
| Next Science TM | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Next Science treatment | Experimental | The 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 Comparator | Saline irrigation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No-Rinse Solution (NS) | Other | The surgical site will be irrigated with NS prior to closure, |
|
| Measure | Description | Time Frame |
|---|---|---|
| infection rate | Joint infection rate after surgery | at 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| QT prolongation | Incidences of QT prolongation and short-term hypocalcemia | up to 24 hours (from the time of irrigation to closure) |
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Inclusion 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:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meriton Ruhani | Contact | (212)434-4724 | ruhanimeriton@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Giles Scuderi | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore University Hospital | Recruiting | Manhasset | New York | 11030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31020036 | Background | 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. | |
| Background | Doyle 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/ | ||
| 24195875 |
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| Saline irrigation | Other | The surgical site will be irrigated with Saline |
|
| Long Island Jewish Medical Center | Recruiting | New Hyde Park | New York | 11040 | United States |
|
| Lenox Hill Hospital | Recruiting | New York | New York | 10075 | United States |
|
| Background |
| Moonesinghe 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. |
| 24055383 | Background | Bilimoria 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. |