Enhanced Disinfection for Hospital Room Contamination

Recruiting at 1 trial location

Overseen By Amanda M Graves, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Under 18, COVID-19, Influenza, RSV, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 week

918 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Sani24, a special disinfectant effective for 24 hours, reduces germs in hospital rooms more effectively than regular cleaning methods. Participants will have their rooms cleaned with either Sani24, a standard disinfectant, or through regular hospital cleaning. The trial targets adult patients who have stayed in their hospital room for at least one night and expect to remain for two or more days, particularly those on contact precautions or with certain positive cultures. As an unphased trial, it offers patients the chance to contribute to important research that could enhance hospital cleanliness and patient safety.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this disinfection method is safe for hospital use?

Research shows that Sani24, a disinfectant effective for 24 hours, works against many germs, including the virus causing COVID-19. The EPA has registered this product, confirming it meets safety standards for its intended use.

EPA-registered disinfectants are widely used and generally safe when used as directed. They effectively kill bacteria, fungi, and viruses.

Both products are designed for cleaning surfaces and should not cause harm if used according to instructions. However, following safety guidelines, such as wearing gloves, is important to prevent possible skin irritation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for enhanced disinfection methods because it explores new ways to reduce hospital room contamination. Unlike standard EPA-registered disinfectants and routine cleaning by hospital staff, Sani24 offers a continuously acting solution that works for 24 hours, thanks to its unique formula containing quaternary ammonium salts. This approach has the potential to provide long-lasting protection against harmful pathogens, which could significantly improve patient safety and reduce infection rates in healthcare settings. By comparing Sani24 with current disinfectants, the trial aims to uncover how effective these new methods are in maintaining a cleaner environment over an extended period.

What evidence suggests that this trial's disinfection methods could be effective for reducing hospital room contamination?

In this trial, participants will be assigned to different treatment arms to evaluate disinfection methods. Research has shown that Sani24, used by participants in one arm, effectively combats many types of germs. It kills germs on contact within a minute and continues to work for 24 hours, tackling tough viruses like norovirus and SARS-CoV-2, the virus that causes COVID-19.

In another arm, participants will use regular disinfectants approved by the EPA, which have also been proven to reduce germs in hospitals. These disinfectants are widely used and effectively kill germs, but they do not provide ongoing protection like Sani24. Both options improve cleanliness, but Sani24 offers the added benefit of continuous protection. ^{2 4 6 7 8}

Who Is on the Research Team?

Deverick Anderson, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adult patients in the hospital who are on contact precautions for any reason or have a positive culture for certain infections upon room admission. They must have spent at least one night in their room and expect to stay another 48 hours.

Inclusion Criteria

Patient spent ≥1 night in room prior to enrollment

On contact precautions (for any reason) and/or has positive culture for EIP at the time of room admission

I am an adult currently admitted to a hospital room.

Exclusion Criteria

Patient stay is expect to be <48 hours

I am under 18 years old.

I am on special precautions due to a C. difficile infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Application of disinfectants and measurement of room contamination over 4 days

1 week

Daily monitoring for 4 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sani24
• Standard EPA-registered disinfectant

Trial Overview The study is testing if using Sani24, a disinfectant with persistent activity for 24 hours, can reduce environmental germs more effectively than standard EPA-registered disinfectants used in routine cleaning.

How Is the Trial Designed?

Group I: Standard EPA-registered disinfectant Experimental Treatment 1 Intervention

Application of standard EPA-registered disinfectant by study team

Group II: Sani24 Experimental Treatment 1 Intervention

Application of a 24-hour continuously acting quaternary ammonium salt disinfectant: Sani24 (PDI Healthcare Inc.) by study team

Group III: Control Active Control 1 Intervention

Routine disinfection completed by hospital staff

Sani24 is already approved in United States for the following indications:

Approved in United States as Sani-24 for:

• Environmental disinfection in hospital rooms
• Control of HAI-causing microorganisms

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

University of North Carolina

Collaborator

Trials

174

Recruited

1,457,000+

Published Research Related to This Trial

The implementation of a dedicated daily disinfection team and a standardized clearance process significantly improved the disinfection of hospital rooms after Clostridium difficile infection, reducing positive culture rates from 67% to just 7%.

Sequential interventions, including fluorescent markers for monitoring cleaning thoroughness and automated ultraviolet radiation, progressively enhanced cleaning effectiveness, with the final intervention achieving an 89% reduction in positive cultures compared to baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An environmental disinfection odyssey: evaluation of sequential interventions to improve disinfection of Clostridium difficile isolation rooms. Sitzlar, B., Deshpande, A., Fertelli, D., et al.[2022]

No-touch disinfection methods, such as ultraviolet (UV) light and hydrogen peroxide (HP) systems, have shown effectiveness in reducing infection rates in hospital rooms, based on a review of 20 clinical trials for UV devices and 8 for HP systems.

Copper-coated surfaces were evaluated as self-disinfecting technology, but the results were mixed, indicating that while no-touch methods are beneficial, their implementation should be considered alongside other infection control practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

..úNo touch..Ñ methods for health care room disinfection: Focus on clinical trials. Weber, DJ., Rutala, WA., Anderson, DJ., et al.[2023]

Most near patient surfaces in hospitals are not cleaned according to existing policies, which increases the risk of patients acquiring pathogens from previous occupants' rooms.

Improving disinfection practices can significantly reduce environmental contamination on high-touch surfaces, with studies showing over 100% improvement in cleaning effectiveness linked to lower pathogen presence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating hygienic cleaning in health care settings: what you do not know can harm your patients. Carling, PC., Bartley, JM.[2010]

The Sani System, an over-heated saturated dry-steam disinfection device, effectively reduced bacterial loads by a factor of 100 in contact plate tests and by a factor of 10 in total bioburden tests, demonstrating its strong bactericidal effectiveness against common hospital pathogens.

In all experimental conditions tested, the Sani System achieved 100% bacterial kill rates for Staphylococcus aureus, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Acinetobacter baumannii, indicating its potential to significantly lower the risk of nosocomial infections in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[In vitro evaluation of bactericidal activity of an over-heated saturated dry atomized steam electro-medical device on inert contaminated surfaces]. Storni, E., Donati, ME., Naldi, S., et al.[2011]

The use of bleach wipes for cleaning patient rooms significantly reduced Clostridium difficile infection (CDI) transmission, with 91% of patients expressing high satisfaction with the cleanliness of their rooms.

While patients generally tolerated the bleach wipes well, especially in medical units, Environmental Services staff reported initial dissatisfaction and respiratory irritation, though their satisfaction improved over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and environmental service employee satisfaction of using germicidal bleach wipes for patient room cleaning. Aronhalt, KC., McManus, J., Orenstein, R., et al.[2020]

'No touch' disinfection methods, such as UV light devices and hydrogen peroxide systems, have been shown to effectively reduce healthcare-associated infections (HAIs) in hospital environments, as demonstrated by multiple clinical trials.

Traditional cleaning methods often leave surfaces contaminated, highlighting the need for validated 'no touch' systems for terminal room disinfection, especially after patients on contact precautions are discharged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'No touch' technologies for environmental decontamination: focus on ultraviolet devices and hydrogen peroxide systems. Weber, DJ., Kanamori, H., Rutala, WA.[2022]

A survey conducted in Rome's largest hospital revealed that 24 out of 39 departments reported using 886 disinfection procedures with 110 different formulations, highlighting the complexity of disinfectant use in healthcare settings.

The study suggests that hospitals should streamline their disinfectant choices and create clear guidelines for usage and waste disposal to enhance safety for both patients and staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Survey of disinfectant usage in a polyclinic in Rome: preliminary results]. Leoni, V., Urso, M., Materazzo, F., et al.[2019]

Disposable wipes play a crucial role in enhancing hospital cleanliness by effectively cleaning and disinfecting both patient skin and hard surfaces.

Improving cleaning levels in hospitals is essential for patient safety, and the use of disposable wipes is a key strategy in ongoing cleanliness campaigns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disposable cleansing wipes. Baker, F., Scott, P., Kingsley, A.[2012]

Chlorine-based germicides are the only cleaning agents that effectively inactivate Clostridium difficile spores at recommended concentrations, while other agents, including those with detergent and hydrogen peroxide, do not have the same efficacy.

Exposure to certain cleaning agents can actually increase the sporulation rate of C. difficile, particularly with detergent-based products, which raises concerns about their use in controlling this pathogen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of hospital cleaning agents and germicides against epidemic Clostridium difficile strains. Fawley, WN., Underwood, S., Freeman, J., et al.[2022]

Seven cleaning-disinfecting products were tested against harmful bacteria, showing that most achieved a greater than 5 log10 reduction in microbial counts after 5 minutes, indicating high efficacy in cleaning and disinfection.

The hydrogen peroxide spray was less effective, particularly against vancomycin-resistant enterococci (VRE), and while ATP measurements indicated cleaning effectiveness, they did not directly correlate with actual reductions in colony-forming units (CFU).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of cleaning-disinfection wipes and sprays against multidrug-resistant outbreak strains. Kenters, N., Huijskens, EGW., de Wit, SCJ., et al.[2020]

Virusolve+ disinfectant wipes completely eliminated MRSA and XDR A. baumannii from contaminated surfaces, demonstrating superior effectiveness in decontamination compared to other cleaning methods.

In contrast, while PAL disinfectant wipes reduced bacterial presence, they did not eliminate it entirely, indicating that Virusolve+ is the most effective option for ensuring safety in hospital environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of disinfectant wipes for decontamination of bacteria on patients' environmental and medical equipment surfaces at Siriraj Hospital. Seenama, C., Tachasirinugune, P., Jintanothaitavorn, D., et al.[2013]

Citations

1. pdihc.com pdihc.com/wp-content/uploads/2020/10/Sani-24-Wipe-FAQ_02228148.pdf

Sani-24® Germicidal Disposable Wipe A: Yes, the Sani-24 Wipe meets the emerging viral pathogen claim based on efficacy claims for norovirus and poliovirus. The customer should follow the ...

2. pdihc.com pdihc.com/wp-content/uploads/2021/07/Sani-24-Technology-Overview_UPDATE_0222_05190655.pdf

Sani-24® Continuously Active Disinfectant1 + Wipe and spray formats provide 1 minute disinfection for a broad spectrum of organisms. + Effective against SARS-CoV-2 (COVID-19). + Bactericidal and ...

3. rhinomedicalsupply.com rhinomedicalsupply.com/products/pdi-sani-wipe%E2%84%A2-non-rinse-food-contact-hard-surface-sanitizing-wipe

PDI SANI-24™ GERMICIDAL WIPE 7" x 12" X-Large ... Sani-24 Germicidal Disposable Wipe has demonstrated effectiveness against viruses similar to Monkeypox virus on hard, nonporous surfaces. Therefore, Sani-24 ...

4. statimusa.com statimusa.com/product/pdi-sani-24-germicidal-disposable-wipes-case/?srsltid=AfmBOoqUevCmMTdj-EqPRa3AySPNSczFHHsiNBZ9qj-6hsbN6xG29TcD

PDI Sani-24 Germicidal Disposable 6" x 7" Wipes Case P26672 It is the first, and only EPA registered disinfectant with the ability to control HAI-causing microorganisms with continuously active disinfection (CAD).

5. hfmmagazine.com hfmmagazine.com/articles/4310-cleaning-and-disinfection-products-for-health-care

Cleaning and disinfection products for health care PDI has introduced a continuously active disinfectant, the Sani-24 Germicidal Disposable Wipe. It kills pathogens on contact within a minute ...

6. pdihc.com pdihc.com/wp-content/uploads/2020/10/SDS-0279-00-English-3.pdf

Sani-24 Germicidal Disposable Wipe Fire residues and contaminated fire extinguishing water must be disposed of in accordance with local regulations. Explosion data. Sensitivity to ...

7. statimusa.com statimusa.com/product/pdi-sani-24-germicidal-disposable-wipes-case/?srsltid=AfmBOoputnwTMRi2iIUFm0djDxm2W5AiiRCRTHHKn-qg0euVvvXnwSH9

PDI Sani-24 Germicidal Disposable 6" x 7" Wipes Case P26672 It is the first, and only EPA registered disinfectant with the ability to control HAI-causing microorganisms with continuously active disinfection (CAD).

8. pdihc.com pdihc.com/wp-content/uploads/2022/05/Sani-24-Germicidal-Disposable-Wipe_Website-Ingredient-Disclosure_05032022.pdf

Sani-24® Germicidal Disposable Wipe SAFETY DATA SHEETS. Sani-24 Germicidal Disposable Wipe. MANUFACTURER. PROFESSIONAL DISPOSABLE INTERNATIONAL, INC (PDI). 400 Chestnut Ridge Road ...