Development and evaluation of the universal ACS NSQIP surgical risk calculator: a decision aid and informed consent tool for patients and surgeons.
Karl Y Bilimoria, Yaoming Liu, Jennifer L Paruch...
https://pubmed.ncbi.nlm.nih.gov/24055383/Actively Recruiting
Led by Northwell Health · Updated on 2025-05-23
936
Participants Needed
3
Research Sites
N/A
Total Duration
Researchers are evaluating the 90-day rate of joint infections in adults undergoing primary hip replacement surgery. This trial compares the use of Next Science No-Rinse Solution NS to the standard saline irrigation SOC to see which method better reduces post-operative joint infections. The study is a randomized, controlled clinical trial conducted at a single site with two parallel groups. Participants will be randomly assigned to one of two groups the experimental group, where the surgical site is irrigated with NS prior to closure and suctioned at the end of treatment, or the control group, where saline irrigation is used. This treatment is applied during surgery just before closing the surgical site. Throughout the study, participants will be monitored for joint infections up to 90 days after surgery. Researchers will also assess any changes in heart rhythm QT prolongation within 24 hours from irrigation to closure. Participants must be available for all scheduled visits and follow study procedures, including transportation to the study site. The total study duration covers the 90-day post-operative period.
CONDITIONS
Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone
M
Meriton Ruhani
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Northwell Health
Lead Sponsor
Next Science TM
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | NS irrigation | Saline irrigation |
|---|---|---|
| What it is | An investigational no‑rinse antimicrobial irrigation solution applied to the surgical site before closure | Standard saline irrigation applied before wound closure |
| Role in trial | Experimental intervention being tested for infection prevention | Active comparator representing standard care |
| Primary use | Used to irrigate the joint during primary replacement surgery to potentially reduce infection within 90 days | Used to irrigate the surgical site as standard practice before wound closure |
| How it is given or performed | Irrigation of surgical site with No‑Rinse Solution prior to closure | Irrigation of surgical site with saline solution prior to closure |
| Evidence status | Effectiveness for reducing 90‑day infection rate is under investigation | Guidelines recommend dilute povidone‑iodine for SSI prevention, but evidence remains limited and non‑specific |
| Important risks | Safety profile has not been established in this clinical setting | Generally considered safe for surgical irrigation |
| Important limitations | Efficacy and safety findings are not yet available; trial is still recruiting | Existing studies show no advantage of antiseptic or antibiotic irrigation over saline; optimal irrigation approach remains unclear |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 hours (from the time of irrigation to closure)
Participants undergo primary joint replacement surgery with the surgical site irrigated using either the No-Rinse Solution or saline before closure.
1 surgery visit (in-person)
Duration - 90 days
Participants are monitored for infection and other outcomes following surgery.
Follow-up visits as scheduled up to 90 days post-surgery
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/31020036/Northwell Health
Lead Sponsor
Next Science TM
Collaborating Sponsor