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

Trial Summary

What is the purpose of this trial?

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

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.

What data supports the effectiveness of the treatment No-Rinse Solution vs Saline Irrigation for Joint Infections?

Research shows that using high-volume saline irrigation can reduce infection rates in surgical sites, which suggests that saline irrigation might be effective in preventing infections in joint surgeries as well. ^{1 2 3 4 5}

Is normal saline safe for use in humans?

Normal saline is generally safe for use in humans, as it is commonly used for wound irrigation and IV flushes. Some studies have noted minor issues like taste and odor disturbances when used in certain ways, but these are not serious safety concerns. ^{2 3 6 7 8}

How does the No-Rinse Solution treatment for joint infections differ from other treatments?

The No-Rinse Solution is unique because it does not require rinsing after application, unlike traditional saline irrigation which involves flushing the area with a saltwater solution. This can make the treatment process quicker and potentially more convenient for both patients and healthcare providers. ^{2 3 9 10 11}

Research Team

Giles Scuderi

Principal Investigator

Northwell Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

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]

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 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Intraoperative incision irrigation with high-volume saline reduces surgical site infection for abdominal infections. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of a new pressurized saline canister versus syringe irrigation for laceration cleansing in the emergency department. [2019]

3. England 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A comparison of wound irrigation solutions used in the emergency department. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Nasal saline for chronic sinonasal symptoms: a randomized controlled trial. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Balanced Salt Solutions for Critically Ill Patients: Nonplused and Back to Basics. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of effects of baby shampoo vs. saline irrigation on endoscopic sinus surgery outcomes and quality of life. [2021]

8. Canada 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. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Water for wound cleansing. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Water for wound cleansing. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

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