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OpenTrials
Completed

NCT Number: NCT05739955

Impact of Enhanced Daily Disinfection on Environmental Contamination in Hospital Rooms

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.

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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 daily disinfection strategies on environmental contamination in acute care hospital rooms.

The trial will be conducted in acute care hospital rooms at Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, and the University of North Carolina Medical Center. In each study room, one half will be randomized to the control arm, and the other half will be randomized to one of the two intervention arms. Two separate randomization steps will occur. First, each room will be randomized to Intervention 1 or Intervention 2. Second, the half of the room to which the intervention will be applied (e.g., right vs. left) will be randomly selected. The control arm will receive no interventions. Rooms randomized to the control arm will undergo routine disinfection via existing Environmental Services (EVS) protocols. All study hospitals routinely use EPA-registered disinfectants for low-level disinfection of hospital room surfaces. Intervention 1 is the standard EPA-registered disinfectant to each study surface and will be applied by the study team. Intervention 2 is a quaternary ammonium, salt-based, 24-hour continuously active germicidal wipe (Sani-24®) to each study surface and will be applied by the study team.

Three different methods will be used for disinfection. No changes to baseline and routine disinfection practices will occur during the study. EVS employees at study hospitals will be responsible for the total room cleaning and disinfection throughout the study. Tasks will be separated between study team members to maintain blinding.Room contamination will be measured before the application of the interventions on study day 1 and every 24 hours for 3 subsequent days, for a total of 4 days. Secondary outcomes include evaluation for epidemiologically important pathogens (EIP), including me staphylococcus aureus (MRSA or MSSA), extended spectrum beta-lactamase (ESBL) or carbapenem-resistant Enterobacteriaceae (CRE) producing Enterobacterales, vancomycin-resistant Enterococci (VRE), vancomycin-susceptible Enterococci (VSE), Acinetobacter spp., and Pseudomonas aeruginosa.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patient admitted to the room
  • Patient spent ≥1 night in room prior to enrollment
  • Anticipated patient stay of ≥48 hours
  • 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
  • Patient age <18, even if on adult ward
  • Patient admitted on respiratory precautions due to coronavirus disease (COVID-19), influenza, or respiratory syncytial virus (RSV)
  • Patient on contact precautions due to C. difficile

Treatment and study plan

Sani24

Other

24-hour continuously acting quaternary ammonium salt disinfectant

Standard EPA-registered disinfectant

Other

Standard EPA-registered disinfectant

Routine Disinfection

Other

Routine disinfection at the study hospital

Primary outcomes

  1. Change in total room contamination in study rooms on study day 2

    Time frame: Baseline (day 1), day 2

    Total contamination, in colony-forming units (CFUs) on environmental surfaces on study days 1 and 2

Secondary outcomes

  1. Change in total room contamination

    Time frame: Day 2, Day 3, Day 4

    Total CFU measured on study days 2, 3, and 4

  2. Frequency of daily disinfection by EVS or unit personnel (control arm) and study personnel (intervention arms)

    Time frame: Day 2, Day 3, Day 4

    Proportion of sample areas with removed ultraviolet glowing gel on study days 2, 3, 4

  3. Total room contamination with epidemiologically important pathogens (EIP)

    Time frame: Day 1, Day 2, Day 3, Day 4

    Number of samples positive for individual EIP

  4. Total contamination on room bed rails

    Time frame: Day 1, Day 2, Day 3, Day 4

    Total CFU measured from room bed rails on study days 1, 2, 3, 4

  5. Total contamination on room footboards

    Time frame: Day 1, Day 2, Day 3, Day 4

    Total CFU measured from room footboards on study days 1, 2, 3, 4

  6. Total contamination on room sinks

    Time frame: Day 1, Day 2, Day 3, Day 4

    Total CFU measured from room sinks on study days 1, 2, 3, 4

  7. Total EIP contamination on room bed rails

    Time frame: Day 1, Day 2, Day 3, Day 4

    Total EIP measured from room bed rails on study days 1, 2, 3, 4

  8. Total EIP contamination on room footboards

    Time frame: Day 1, Day 2, Day 3, Day 4

    Total EIP measured from room footboards on study days 1, 2, 3, 4

  9. Total EIP contamination on room sinks

    Time frame: Day 1, Day 2, Day 3, Day 4

    Total EIP measured from room sinks on study days 1, 2, 3, 4

  10. Proportion of positive environmental cultures

    Time frame: Day 1, Day 2, Day 3, Day 4

    Frequency of growth of any organism on any of the surfaces and on each surface.

  11. Proportion of EIP positive environmental cultures

    Time frame: Day 1, Day 2, Day 3, Day 4

    Frequency of EIP growth on any of the surfaces and on each surface.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • University of North Carolina

Registry information

Official study title

Determining the Impact of Enhanced Daily Disinfection on Environmental Contamination in Acute Care Hospital Rooms: A 3-arm Multicenter Blinded Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 22, 2023
Registry last updated
Apr 6, 2026

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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