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

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.

Study Overview

• Status: Completed
• Conditions: Disinfection
• Intervention / Treatment: Other: Sani24; Other: Routine Disinfection

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)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inpatient rooms housing adult patients on contact precautions

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: PDI Healthcare Inc.
• Investigators: Principal Investigator: Nick Turner, MD, Duke School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2019
• Primary Completion (Actual): March 17, 2022
• Study Completion (Actual): March 17, 2022

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Disinfection, contamination
• Other Study ID Numbers: Pro00103576

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