No-Rinse Solution vs Saline Irrigation for Joint Infections

Recruiting at 2 trial locations

Overseen By Meriton Ruhani

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Allergy to study products, Covid-19, Prolonged QT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

936 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether a No-Rinse Solution (NS) reduces joint infections more effectively than the standard saline rinse during hip replacements. It targets individuals scheduled for hip replacement surgery, particularly those with certain health conditions such as poorly managed diabetes, high blood pressure, or smoking habits. Participants must be able to travel to the study site and commit to all study procedures.

As an unphased trial, this study allows participants to contribute to important research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on rheumatological medication for inflammatory arthritis, it seems you can continue as it is part of the inclusion criteria.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the No-Rinse Solution, also known as XPERIENCE, is generally easy for patients to handle. Studies have found that this solution can greatly reduce bacteria, which may help prevent infections. Specifically, research showed a large drop in bacteria levels, decreasing by 10,000 to 100 million times within just five minutes.

Regarding safety, major side effects linked to the No-Rinse Solution have not been reported. The ingredients, such as citric acid and sodium citrate, are commonly found in products safe for people to use. Although this solution isn't yet FDA-approved for joint infections, its use in other surgeries supports its safety.

Overall, while no treatment is completely without risk, current evidence suggests the No-Rinse Solution is safe and manageable for patients, making it a promising option for reducing infections after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the No-Rinse Solution (NS) because it offers a new approach to treating joint infections. Unlike the standard saline irrigation, which requires flushing the area with a saltwater solution, NS is applied directly and then suctioned off, potentially simplifying the procedure. This method could reduce the risk of infection by minimizing the need for additional fluids and equipment, making it easier for surgeons and potentially more comfortable for patients. The innovative application could also lead to faster recovery times, which is always a plus for those facing surgery.

What evidence suggests that this trial's treatments could be effective for reducing joint infections?

Research has shown that the No-Rinse Solution (NS), which participants in this trial may receive, might effectively reduce infections after joint surgery. One study reported no joint infections within 90 days of using this solution. Other research demonstrated its strong ability to kill bacteria, reducing them by thousands to millions in lab tests. This trial will compare NS with regular saline irrigation, the standard of care, to evaluate their effectiveness in preventing infections. These promising results support NS's potential use in surgeries to help prevent infections. ^{1 2 3 4 6}

Who Is on the Research Team?

Giles Scuderi

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

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.

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: 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.

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo primary hip replacement surgery with irrigation using either Next Science No-Rinse Solution or standard saline

1 day

1 visit (in-person)

Immediate Post-operative Monitoring

Participants are monitored for incidences of QT prolongation and short-term hypocalcemia

24 hours

Follow-up

Participants are monitored for joint infection rate after surgery

90 days

What Are the Treatments Tested in This Trial?

Interventions

• No-Rinse Solution (NS)
• Saline irrigation

Trial Overview 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.

How Is the Trial Designed?

Group I: The Next Science treatment Experimental Treatment 1 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 Care Active Control 1 Intervention

Saline irrigation

No-Rinse Solution (NS) is already approved in United States for the following indications:

Approved in United States as XPERIENCE No Rinse Solution for:

• Prevention of surgical site infections in orthopedic surgeries, including hip and knee replacements

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Next Science TM

Industry Sponsor

Trials

17

Recruited

9,700+

Next Science

Collaborator

Trials

2

Recruited

1,600+

Published Research Related to This Trial

The study involved 550 patients with lacerations and found that using a pressurized canister for saline irrigation significantly reduced irrigation time to an average of 3.9 minutes compared to 7.3 minutes for traditional syringe irrigation.

While the complication rates were similar between the two methods (5.0% for the canister and 3.6% for the syringe), the pressurized canister offers a more efficient and standardized approach to wound irrigation, which could improve wound management practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a new pressurized saline canister versus syringe irrigation for laceration cleansing in the emergency department. Chisholm, CD., Cordell, WH., Rogers, K., et al.[2019]

In a study of 77 patients who underwent functional endoscopic sinus surgery (FESS), nasal irrigation with diluted baby shampoo (BS) significantly improved surgical outcomes, particularly in reducing nasal discharge and crust formation at 1 month postoperatively compared to normal saline solution (NSS).

Patients using BS also reported better quality of life improvements, as measured by the Sinonasal Outcome Test (SNOT-22), especially in psychological and rhinological aspects, although these benefits were not sustained at later follow-up periods (3, 6, or 12 months).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of effects of baby shampoo vs. saline irrigation on endoscopic sinus surgery outcomes and quality of life. Tulaci, KG., Arslan, E., Tulaci, T., et al.[2021]

In a study involving 50 pediatric patients aged 6 to 18 years, 72% reported taste and odor disturbances after flushing IV lines with prefilled syringes of normal saline, compared to only 4% with freshly prepared saline, indicating a significant difference (p < 0.001).

The findings suggest that the plastic materials in commercially available prefilled syringes may leach volatile substances into the saline, causing these disturbances, highlighting the importance of preparation methods in minimizing patient discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taste and Odour Disturbances in Pediatric Patients Undergoing IV Flush with Normal Saline Administered by Prefilled or Freshly Prepared Syringes: Randomized Single-Blind Study. Mancini, D., Vaillancourt, R., Pouliot, A., et al.[2019]

In a study of 414 patients undergoing emergency laparotomy for abdominal infections, high-volume normal saline (NS) irrigation significantly reduced the overall surgical site infection (SSI) rate from 26.1% in the control group to 10.6% in the irrigation group.

Patients receiving NS irrigation also experienced fewer complications, such as lower rates of incision seroma and shorter antibiotic use, indicating that this method not only helps prevent infections but may also improve overall recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative incision irrigation with high-volume saline reduces surgical site infection for abdominal infections. Wang, J., Lv, W., Xu, S., et al.[2022]

In a study involving 631 patients with soft tissue lacerations, there was no significant difference in infection rates between wounds irrigated with tap water (TW) and those irrigated with sterile normal saline (SS), suggesting that TW is a safe alternative.

While the infection rate was slightly lower in the TW group (3.5%) compared to the SS group (6.4%), the difference was not statistically significant, indicating that TW could be a cost-effective option for wound irrigation without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Water is a safe and effective alternative to sterile normal saline for wound irrigation prior to suturing: a prospective, double-blind, randomised, controlled clinical trial. Weiss, EA., Oldham, G., Lin, M., et al.[2021]

In a study involving 400 patients who had their third molars removed, the overall incidence of localized alveolitis was 4.5% and infection was 1.7%, indicating these complications are relatively uncommon after surgery.

The use of different antimicrobial mouth rinses (chloramine-T, povidone iodine, sodium bicarbonate) did not significantly reduce the incidence of localized alveolitis or infections compared to normal saline, suggesting that normal saline may be just as effective as these rinses in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of antimicrobial mouth rinses on the incidence of localized alveolitis and infection following mandibular third molar oral surgery. Sweet, JB., Macynski, AA.[2022]

Recent large randomized controlled trials comparing normal saline (NS) and balanced salt solutions (BSSs) in critically ill patients showed no significant differences in mortality rates, despite some earlier studies suggesting benefits for BSSs.

Methodological issues in these trials, such as varying designs, clinician discretion in treatment, and lack of power to detect subgroup differences, highlight the need for further research to determine the optimal resuscitation fluid for critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balanced Salt Solutions for Critically Ill Patients: Nonplused and Back to Basics. Kopp, BJ., Lenney, M., Erstad, BL.[2023]

Using tap water to cleanse acute wounds may lower the infection rate compared to normal saline, although the evidence is limited and based on a small number of trials.

There is no significant difference in infection rates between wounds cleansed with tap water and those that were not cleansed at all, suggesting that in the absence of clean water, alternatives like boiled or distilled water can be effective for wound cleansing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Water for wound cleansing. Fernandez, R., Griffiths, R., Ussia, C.[2018]

Using tap water to cleanse acute wounds in adults does not increase the risk of infection and may actually reduce it compared to normal saline, based on a review of 11 trials.

For chronic wounds, the evidence is less clear, but there is no strong indication that cleansing wounds, whether with water or saline, significantly improves healing or reduces infection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Water for wound cleansing. Fernandez, R., Griffiths, R.[2020]

In a study of 127 adults with chronic nasal and sinus symptoms, nasal irrigations using large volumes and low positive pressure significantly improved quality of life, as shown by lower SNOT-20 scores compared to saline sprays over an 8-week period.

At the 8-week mark, only 40% of patients using the irrigation method reported frequent symptoms, compared to 61% in the spray group, indicating that the irrigation method was more effective in reducing symptom frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal saline for chronic sinonasal symptoms: a randomized controlled trial. Pynnonen, MA., Mukerji, SS., Kim, HM., et al.[2015]

In a study involving 531 patients, the use of normal saline (NS), 1% povidone-iodine solution (PI), and pluronic F-68 (Shur-Clens) (SC) for wound irrigation showed no significant difference in infection rates, with infection rates of 6.9%, 4.3%, and 5.6% respectively.

Normal saline was found to be the most cost-effective option among the three treatments, suggesting it is a suitable choice for wound irrigation in emergency departments without compromising safety or efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of wound irrigation solutions used in the emergency department. Dire, DJ., Welsh, AP.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05519007

Rate of Total Joint Infection 90-day After Surgery Following ... Clinical Evaluation of the Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone.

2. journaloei.scholasticahq.com journaloei.scholasticahq.com/article/121295-the-use-of-a-novel-surgical-irrigant-may-be-associated-with-decreased-incidence-of-surgical-site-infections

The Use of a Novel Surgical Irrigant May Be Associated with ... This investigation evaluated a novel antimicrobial surgical irrigation solution, XPerience (XP) (Next Science LLC, Jacksonville, FL), with proven high & ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11144508/

Efficacy of a Novel Intraoperative Surgical Irrigant in ... A unique intraoperative surgical irrigant was used which resulted in zero incidences of periprosthetic joint infection within 90 days post index surgery.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11001957/

Real-World Evidence of the Impact of a Novel Surgical ... The primary objective of this retrospective study was to evaluate the impact of a novel surgical irrigant called XPERIENCE® Advanced Surgical ...

5. biospace.com biospace.com/new-study-finds-xperience-no-rinse-solution-has-persistent-efficacy-against-both-planktonic-bacteria-and-bacterial-biofilms

New Study Finds XPERIENCE™ No Rinse Solution Has ... In the in vitro study, XPERIENCE demonstrated 4-log to 6-log reductions in planktonic bacteria after five minutes, and 4-log to 8-log reductions ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/os.14052

Efficacy of a Novel Intraoperative Surgical Irrigant in ... XPERIENCE was designed as a no-rinse intraoperative surgical irrigation solution. It consists of citric acid, sodium citrate, and sodium lauryl ...