Impact of Enhanced Daily Disinfection on Environmental Contamination in Hospital Rooms

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Disinfection

Intervention / Treatment
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* Other: Sani24
* Other: Standard EPA-registered disinfectant
* Other: Routine Disinfection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each participant's inpatient room are enrolled in one of the interventions and control arms at the same time.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sani24<br>Application of a 24-hour continuously acting quaternary ammonium salt disinfectant: Sani24 (PDI Healthcare Inc.) by study team | Other: Sani24<br>* 24-hour continuously acting quaternary ammonium salt disinfectant<br>|
| Experimental: Standard EPA-registered disinfectant<br>Application of standard EPA-registered disinfectant by study team | Other: Standard EPA-registered disinfectant<br>* Standard EPA-registered disinfectant<br>|
| Active Comparator: Control<br>Routine disinfection completed by hospital staff | Other: Routine Disinfection<br>* Routine disinfection at the study hospital<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline (day 1), day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total room contamination | Total CFU measured on study days 2, 3, and 4 | 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 | Day 2, Day 3, Day 4 | 
| Total room contamination with epidemiologically important pathogens (EIP) | Number of samples positive for individual EIP | 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 | 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 | 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 | Day 1, Day 2, Day 3, Day 4 | 
| Total EIP contamination on room bed rails | Total EIP measured from room bed rails on study days 1, 2, 3, 4 | 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 | 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 | 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. | 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. | Day 1, Day 2, Day 3, Day 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Disinfection, Contamination