Impact of Enhanced Daily Disinfection on Environmental Contamination in Hospital Rooms

Last updated: March 19, 2025
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sterilization

Treatment

Sani24

Routine Disinfection

Standard EPA-registered disinfectant

Clinical Study ID

NCT05739955
Pro00112526
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thetime of room admission

Exclusion

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 Design

Total Participants: 918
Treatment Group(s): 3
Primary Treatment: Sani24
Phase:
Study Start date:
February 13, 2023
Estimated Completion Date:
February 28, 2026

Study 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.

Connect with a study center

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

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