Clinical trial NCT05739955: Impact of Enhanced Daily Disinfection on Environmental Contamination in Hospital Rooms
Official title: Determining the Impact of Enhanced Daily Disinfection on Environmental Contamination in Acute Care Hospital Rooms: A 3-arm Multicenter Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disinfection
Keywords: Disinfection
Contamination
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of North Carolina
First posted: 2023-02-22
Enrollment: 918
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each participant's inpatient room are enrolled in one of the interventions and control arms at the same time.
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in total room contamination in study rooms on study day 2
timeFrame: Baseline (day 1), day 2
Secondary outcomes:
measure: Change in total room contamination
timeFrame: Day 2, Day 3, Day 4
measure: Frequency of daily disinfection by EVS or unit personnel (control arm) and study personnel (intervention arms)
timeFrame: Day 2, Day 3, Day 4
measure: Total room contamination with epidemiologically important pathogens (EIP)
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: Total contamination on room bed rails
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: Total contamination on room footboards
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: Total contamination on room sinks
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: Total EIP contamination on room bed rails
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: Total EIP contamination on room footboards
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: Total EIP contamination on room sinks
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: Proportion of positive environmental cultures
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: Proportion of EIP positive environmental cultures
timeFrame: Day 1, Day 2, Day 3, Day 4
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Deverick Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References: