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

Not Applicable

Completed

• Conditions: Disinfection
• Interventions: Other: Sani24; Other: Routine Disinfection

• Registration Number: NCT05560321
• Lead Sponsor: Duke University

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)

Study Timeline

• Study Start: 2019-08-22
• Primary Completion: 2022-03-17
• Study Completion: 2022-03-17
• Status Verified: 2022-09
• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-09-26
• Last Update Submitted: 2022-09-26
• Study First Posted: 2022-09-29
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Inpatient rooms housing adult patients on contact precautions

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Routine Disinfection	Application of a 24-hour continuously acting quaternary ammonium salt disinfectant: Sani24 (PDI Healthcare Inc.) by study team
Intervention	Sani24	Application of a 24-hour continuously acting quaternary ammonium salt disinfectant: Sani24 (PDI Healthcare Inc.) by study team
Control	Routine Disinfection	Routine disinfection completed by hospital staff

Primary Outcome Measures

Name	Time	Method
Total room contamination	Day 1	Total contamination, in colony-forming units (CFUs) on environmental surfaces on study day 1

Secondary Outcome Measures

Name	Time	Method
Clinically important pathogens (CIPs) in samples	Day 1	Proportion of samples positive for individual CIP
Baseline contamination (CFUs and CIPs) of sample areas	Day 0	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
Compliance of routine disinfection	Day 1	Proportion of sample areas with removed ultraviolet glowing gel on study day 1

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States