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OpenTrials
Completed

NCT Number: NCT05560321

Measuring the Impact of an Enhanced Strategy for Daily Disinfection in Acute Care Hospital Rooms

To determine the effectiveness of an enhanced strategy for daily disinfection in acute care hospital rooms comparing the addition of sani24 to routine daily cleaning versus the control of routine daily cleaning.

Completed

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27710, United States

About this study

The study Investigator will evaluate the effectiveness of a) adding sani24 to the standard daily cleaning and b) routine daily disinfection in acute care hospital rooms to measure the reduction in bioburden. In other words, the study aims to answer the following research question: does the addition of an additional disinfection technology (Sani24) decrease the environmental bioburden in inpatient hospital compared to routine disinfection?

This trial was conducted in acute care hospital rooms at Duke University Hospital in Durham, North Carolina from November 2021 to March 2022. Room surfaces were divided in two (e.g., right vs. left), allowing each patient room to serve as its own control. The intervention was a quaternary ammonium salt-based 24-hour continuously active germicidal wipe, Sani-24 (PDI Healthcare, Woodcliff, NJ) that was applied in addition to routine disinfection. The control arm received no intervention beyond routine disinfection. Environmental services were blinded to study arms and no changes to routine cleaning protocols occurred during the study period. Room contamination was measured immediately before the application of the disinfectant (study day 0) and 24-hours later (day 1). Secondary outcomes included evaluation for clinically important pathogens (CIP), including methicillin-resistant staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE) and carbapenem-resistant Enterobacteriaceae (CRE)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inpatient rooms housing adult patients on contact precautions

Exclusion criteria

-

Treatment and study plan

Sani24

Other

Disinfectant

Routine Disinfection

Other

Routine disinfection at the study hospital

Primary outcomes

  1. Total room contamination

    Time frame: Day 1

    Total contamination, in colony-forming units (CFUs) on environmental surfaces on study day 1

Secondary outcomes

  1. Clinically important pathogens (CIPs) in samples

    Time frame: Day 0

    Proportion of samples positive for individual CIP

  2. Clinically important pathogens (CIPs) in samples

    Time frame: Day 1

    Proportion of samples positive for individual CIP

  3. Baseline contamination (CFUs and CIPs) of sample areas

    Time frame: Day 0

    Similarity of baseline contamination measured in CFUs and proportion of samples positive for CIPs between sample area sides on study day 0 before application of the intervention

  4. Compliance of routine disinfection

    Time frame: Day 1

    Proportion of sample areas with removed ultraviolet glowing gel on study day 1

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • PDI Healthcare Inc.

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 29, 2022
Registry last updated
Sep 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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