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

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT05560321

Collaborator

PDI Healthcare Inc. (Other)

Enrollment

Location

Arms

30.8

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Disinfection	Other: Sani24 Other: Routine Disinfection	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Each participant's inpatient room was enrolled in both the intervention and control arms at the same time.Each participant's inpatient room was enrolled in both the intervention and control arms at the same time.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Triple blind - exception of the study team member applying the disinfectant product (intervention)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Aug 22, 2019

Actual Primary Completion Date :

Mar 17, 2022

Actual Study Completion Date :

Mar 17, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Total room contamination [Day 1]
Total contamination, in colony-forming units (CFUs) on environmental surfaces on study day 1

Secondary Outcome Measures

Clinically important pathogens (CIPs) in samples [Day 0]
Proportion of samples positive for individual CIP
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Inpatient rooms housing adult patients on contact precautions

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University	Durham	North Carolina	United States	27710

Sponsors and Collaborators

Duke University
PDI Healthcare Inc.

Investigators

Principal Investigator: Nick Turner, MD, Duke School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Duke University

ClinicalTrials.gov Identifier:

NCT05560321

Other Study ID Numbers:

Pro00103576

First Posted:

Sep 29, 2022

Last Update Posted:

Sep 29, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Duke University

Disinfection, contamination

Study Results

No Results Posted as of Sep 29, 2022