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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if enhanced daily application of disinfectant with persistent 24-hour activity decreases the environmental bioburden compared to standard practice.

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 data supports the effectiveness of the treatment Sani-24 Surface Disinfectant Cleaner Germicidal?

Research shows that cleaning and disinfection products can significantly reduce bacteria on surfaces, which helps prevent the spread of infections in hospitals. Although not directly about Sani-24, studies on similar disinfectants indicate they are effective in reducing harmful bacteria and improving hygiene in healthcare settings. ^{1 2 3 4 5}

Is the enhanced disinfection treatment generally safe for humans?

Some studies suggest that while disinfectant wipes are effective for cleaning, there can be concerns about bleach wipes causing respiratory irritation for staff, although patient satisfaction with room cleanliness is generally high. ^{1 4 6 7 8}

How is the treatment Sani24 different from other disinfection methods?

Sani24 is unique because it combines cleaning and disinfection in one product, which can be more efficient than using separate products for each step. This dual action may help reduce the spread of multidrug-resistant organisms in hospital rooms more effectively than traditional methods. ^{2 4 9 10 11}

Research Team

Deverick Anderson, MD

Principal Investigator

Duke University

Eligibility Criteria

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

I am an adult currently admitted to a hospital room.

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

Exclusion Criteria

Patient stay is expect to be <48 hours

I am hospitalized with special measures for COVID-19, flu, or RSV.

I am under 18 years old.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

'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]

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]

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]

References

1. Thailand pubmed.ncbi.nlm.nih.gov

Effectiveness of disinfectant wipes for decontamination of bacteria on patients' environmental and medical equipment surfaces at Siriraj Hospital. [2013]

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

Effectiveness of cleaning-disinfection wipes and sprays against multidrug-resistant outbreak strains. [2020]

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

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

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

Efficacy of hospital cleaning agents and germicides against epidemic Clostridium difficile strains. [2022]

5. Italy 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]. [2011]

6. Italy pubmed.ncbi.nlm.nih.gov

[Survey of disinfectant usage in a polyclinic in Rome: preliminary results]. [2019]

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

Patient and environmental service employee satisfaction of using germicidal bleach wipes for patient room cleaning. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Disposable cleansing wipes. [2012]

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

'No touch' technologies for environmental decontamination: focus on ultraviolet devices and hydrogen peroxide systems. [2022]

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

..úNo touch..Ñ methods for health care room disinfection: Focus on clinical trials. [2023]

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

An environmental disinfection odyssey: evaluation of sequential interventions to improve disinfection of Clostridium difficile isolation rooms. [2022]