Impact of Enhanced Daily Disinfection on Environmental Contamination in Hospital Rooms

Disinfection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05739955
• Other study ID #: Pro00112526
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: February 2026

Study information

• Verified date: March 2024
• Source: Duke University
• Contact: Amanda M Graves, MPH
• Phone: 919-681-7957
• Email: amanda.m.graves[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 918
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disinfection

Intervention

Other:
• Sani24
24-hour continuously acting quaternary ammonium salt disinfectant
• Standard EPA-registered disinfectant
Standard EPA-registered disinfectant
• Routine Disinfection
Routine disinfection at the study hospital

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	University of North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in total room contamination	Total CFU measured on study days 2, 3, and 4	Day 2, Day 3, Day 4
Secondary	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
Secondary	Total room contamination with epidemiologically important pathogens (EIP)	Number of samples positive for individual EIP	Day 1, Day 2, Day 3, Day 4
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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