Measuring the Impact of an Enhanced Strategy for Daily Disinfection in Acute Care Hospital Rooms

Study Overview
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Brief Summary
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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
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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)

Official Title
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Measuring the Impact of an Enhanced Strategy for Daily Disinfection in Acute Care Hospital Rooms

Conditions
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Disinfection

Intervention / Treatment
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* Other: Sani24
* Other: Routine Disinfection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatient rooms housing adult patients on contact precautions Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each participant's inpatient room was enrolled in both the intervention and control arms at the same time.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Application of a 24-hour continuously acting quaternary ammonium salt disinfectant: Sani24 (PDI Healthcare Inc.) by study team | Other: Sani24<br>* Disinfectant<br>Other: Routine Disinfection<br>* Routine disinfection at the study hospital<br>|
| Active Comparator: Control<br>Routine disinfection completed by hospital staff | Other: Routine Disinfection<br>* Routine disinfection at the study hospital<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total room contamination | Total contamination, in colony-forming units (CFUs) on environmental surfaces on study day 1 | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically important pathogens (CIPs) in samples | Proportion of samples positive for individual CIP | Day 0 | 
| Clinically important pathogens (CIPs) in samples | Proportion of samples positive for individual CIP | Day 1 | 
| Baseline contamination (CFUs and CIPs) of sample areas | Similarity of baseline contamination measured in CFUs and proportion of samples positive for CIPs between sample area sides on study day 0 before application of the intervention | Day 0 | 
| Compliance of routine disinfection | Proportion of sample areas with removed ultraviolet glowing gel on study day 1 | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Disinfection, contamination