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

Disinfection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05560321
• Other study ID #: Pro00103576
• Status: Completed
• Phase: N/A
• Start date: August 22, 2019
• Est. completion date: March 17, 2022

Study information

• Verified date: September 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 17, 2022
• Est. primary completion date: March 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inpatient rooms housing adult patients on contact precautions

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Disinfection

Intervention

Other:
• Sani24
Disinfectant
• Routine Disinfection
Routine disinfection at the study hospital

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	PDI Healthcare Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total room contamination	Total contamination, in colony-forming units (CFUs) on environmental surfaces on study day 1	Day 1
Secondary	Clinically important pathogens (CIPs) in samples	Proportion of samples positive for individual CIP	Day 0
Secondary	Clinically important pathogens (CIPs) in samples	Proportion of samples positive for individual CIP	Day 1
Secondary	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
Secondary	Compliance of routine disinfection	Proportion of sample areas with removed ultraviolet glowing gel on study day 1	Day 1