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Antimicrobial Agent

No-Rinse Solution vs Saline Irrigation for Joint Infections

N/A

Recruiting

Led By Giles Scuderi

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 90 days

Awards & highlights

Study Summary

This trial will compare the rate of joint infections in people who undergo hip replacements and are treated with Next Science No-Rinse Solution versus those treated with SOC (saline irrigation). The Next Science treatment arm is expected to have a greater reduction in the rate of joint infections than the SOC arm.

Who is the study for?

This trial is for adults aged 65 or older who are scheduled for primary hip replacement surgery and have certain health conditions like uncontrolled diabetes, heart disease, obesity, or use nicotine. They must be able to follow the study plan and attend all visits. People with allergies to study products, Covid-19 infection at screening time, or issues with anesthesia cannot join.Check my eligibility

What is being tested?

The trial is testing if a new No-Rinse Solution (NS) can better prevent joint infections within 90 days after hip replacement surgery compared to standard saline irrigation. Participants will be randomly assigned to either the NS treatment group or the saline group in this controlled study.See study design

What are the potential side effects?

Potential side effects of the interventions are not specified in the provided information but may include typical surgical risks such as irritation at the site of application or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

infection rate

Secondary outcome measures

QT prolongation

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: The Next Science treatmentExperimental Treatment1 Intervention

The surgical site will be irrigated with NS prior to closure, which will be suctioned at the end of the treatment time

Group II: Standard of CareActive Control1 Intervention

Saline irrigation

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor

459 Previous Clinical Trials

470,037 Total Patients Enrolled

Next Science TMIndustry Sponsor

15 Previous Clinical Trials

8,588 Total Patients Enrolled

Next ScienceUNKNOWN

1 Previous Clinical Trials

700 Total Patients Enrolled

Media Library

No-Rinse Solution (NS) (Antimicrobial Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05519007 — N/A

Joint Infections Research Study Groups: The Next Science treatment, Standard of Care

Joint Infections Clinical Trial 2023: No-Rinse Solution (NS) Highlights & Side Effects. Trial Name: NCT05519007 — N/A

No-Rinse Solution (NS) (Antimicrobial Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05519007 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies open to participants in this trial?

"As detailed on clinicaltrials.gov, this medical trial is presently accepting applications from prospective candidates. The original posting date was September 19th 2022, with the most recent amendment to the study taking place on September 28th 2022."

Answered by AI

How many participants are being incorporated into this experiment?

"Affirmative. Clinicaltrials.gov hosts data that corroborates this clinical trial is currently looking for candidates; it was first posted on September 19th, 2022 and amended most recently on the 28th of the same month. The study requires 936 participants enrolled at 3 sites in total."

Answered by AI

Recent research and studies

Arthroplasty TodayJournal

Risk Stratification in Primary Total Joint Arthroplasty: The Current State of Knowledge

Gronbeck, Christian, Mark P. Cote, Jay R. Lieberman, and Mohamad J. Halawi. 2019. “Risk Stratification in Primary Total Joint Arthroplasty: The Current State of Knowledge”. Arthroplasty Today. Elsevier BV. doi:10.1016/j.artd.2018.10.002.

Journal of the American College of SurgeonsJournal

Development and Evaluation of the Universal ACS NSQIP Surgical Risk Calculator: A Decision Aid and Informed Consent Tool for Patients and Surgeons

Bilimoria, Karl Y., Yaoming Liu, Jennifer L. Paruch, Lynn Zhou, Thomas E. Kmiecik, Clifford Y. Ko, and Mark E. Cohen. 2013. “Development and Evaluation of the Universal ACS NSQIP Surgical Risk Calculator: A Decision Aid and Informed Consent Tool for Patients and Surgeons”. Journal of the American College of Surgeons. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.jamcollsurg.2013.07.385.

AnesthesiologyJournal

Risk Stratification Tools for Predicting Morbidity and Mortality in Adult Patients Undergoing Major Surgery

Moonesinghe, Suneetha Ramani, Michael G. Mythen, Priya Das, Kathryn M. Rowan, and Michael P. W. Grocott. 2013. “Risk Stratification Tools for Predicting Morbidity and Mortality in Adult Patients Undergoing Major Surgery”. Anesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aln.0b013e3182a4e94d.

clinicaltrials.govStudy