Impact of Enhanced Daily Disinfection on Environmental Contamination in Hospital Rooms

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

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.

Study Overview

• Status: Recruiting
• Conditions: Disinfection
• Intervention / Treatment: Other: Routine Disinfection; Other: Sani24; Other: Standard EPA-registered disinfectant

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.

• Study Type: Interventional
• Enrollment (Estimated): 918
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amanda M Graves, MPH; Phone Number: 919-681-7957; Email: amanda.m.graves@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University
      • Contact: Amanda M Graves, MPH; Phone Number: 919-681-7957; Email: amanda.m.graves@duke.edu
      • Principal Investigator: Deverick Anderson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: University of North Carolina
• Investigators: Principal Investigator: Deverick Anderson, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Disinfection; Contamination
• Additional Relevant MeSH Terms: Anti-Infective Agents; Disinfectants
• Other Study ID Numbers: Pro00112526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data will be reported in aggregate.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No