Clinical trial NCT05560321: Measuring the Impact of an Enhanced Strategy for Daily Disinfection in Acute Care Hospital Rooms
Official title: Measuring the Impact of an Enhanced Strategy for Daily Disinfection in Acute Care Hospital Rooms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disinfection
Keywords: Disinfection, contamination
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: PDI Healthcare Inc.
First posted: 2022-09-29
Enrollment: 50
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 was enrolled in both the intervention and control arms at the same time.
Primary purpose: BASIC_SCIENCE

Brief summary: To determine the effectiveness of an enhanced strategy for daily disinfection in acute care hospital rooms comparing the addition of sani24 to routine daily cleaning versus the control of routine daily cleaning.

Detailed description: The study Investigator will evaluate the effectiveness of a) adding sani24 to the standard daily cleaning and b) routine daily disinfection in acute care hospital rooms to measure the reduction in bioburden. In other words, the study aims to answer the following research question: does the addition of an additional disinfection technology (Sani24) decrease the environmental bioburden in inpatient hospital compared to routine disinfection?

This trial was conducted in acute care hospital rooms at Duke University Hospital in Durham, North Carolina from November 2021 to March 2022. Room surfaces were divided in two (e.g., right vs. left), allowing each patient room to serve as its own control. The intervention was a quaternary ammonium salt-based 24-hour continuously active germicidal wipe, Sani-24 (PDI Healthcare, Woodcliff, NJ) that was applied in addition to routine disinfection. The control arm received no intervention beyond routine disinfection. Environmental services were blinded to study arms and no changes to routine cleaning protocols occurred during the study period. Room contamination was measured immediately before the application of the disinfectant (study day 0) and 24-hours later (day 1). Secondary outcomes included evaluation for clinically important pathogens (CIP), including methicillin-resistant staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE) and carbapenem-resistant Enterobacteriaceae (CRE)

Eligibility criteria: Inclusion Criteria:

* Inpatient rooms housing adult patients on contact precautions

Exclusion Criteria:

-

Primary outcomes:
measure: Total room contamination
timeFrame: Day 1
Secondary outcomes:
measure: Clinically important pathogens (CIPs) in samples
timeFrame: Day 0
measure: Clinically important pathogens (CIPs) in samples
timeFrame: Day 1
measure: Baseline contamination (CFUs and CIPs) of sample areas
timeFrame: Day 0
measure: Compliance of routine disinfection
timeFrame: Day 1
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke School of Medicine
name: Nick Turner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Warren BG, Barrett A, Graves A, King C, Turner NA, Anderson DJ. An Enhanced Strategy for Daily Disinfection in Acute Care Hospital Rooms: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2242131. doi: 10.1001/jamanetworkopen.2022.42131.