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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
475
24-hour continuously acting quaternary ammonium salt disinfectant
Standard EPA-registered disinfectant
Routine disinfection at the study hospital
Duke University
Durham, North Carolina, United States
Change in total room contamination in study rooms on study day 2
Total contamination, in colony-forming units (CFUs) on environmental surfaces on study days 1 and 2
Time frame: Baseline (day 1), day 2
Change in total room contamination
Total CFU measured on study days 2, 3, and 4
Time frame: Day 2, Day 3, Day 4
Frequency of daily disinfection by EVS or unit personnel (control arm) and study personnel (intervention arms)
Proportion of sample areas with removed ultraviolet glowing gel on study days 2, 3, 4
Time frame: Day 2, Day 3, Day 4
Total room contamination with epidemiologically important pathogens (EIP)
Number of samples positive for individual EIP
Time frame: Day 1, Day 2, Day 3, Day 4
Total contamination on room bed rails
Total CFU measured from room bed rails on study days 1, 2, 3, 4
Time frame: Day 1, Day 2, Day 3, Day 4
Total contamination on room footboards
Total CFU measured from room footboards on study days 1, 2, 3, 4
Time frame: Day 1, Day 2, Day 3, Day 4
Total contamination on room sinks
Total CFU measured from room sinks on study days 1, 2, 3, 4
Time frame: Day 1, Day 2, Day 3, Day 4
Total EIP contamination on room bed rails
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Total EIP measured from room bed rails on study days 1, 2, 3, 4
Time frame: Day 1, Day 2, Day 3, Day 4
Total EIP contamination on room footboards
Total EIP measured from room footboards on study days 1, 2, 3, 4
Time frame: Day 1, Day 2, Day 3, Day 4
Total EIP contamination on room sinks
Total EIP measured from room sinks on study days 1, 2, 3, 4
Time frame: Day 1, Day 2, Day 3, Day 4
Proportion of positive environmental cultures
Frequency of growth of any organism on any of the surfaces and on each surface.
Time frame: Day 1, Day 2, Day 3, Day 4
Proportion of EIP positive environmental cultures
Frequency of EIP growth on any of the surfaces and on each surface.
Time frame: Day 1, Day 2, Day 3, Day 4