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

NCT ID: NCT05560321

Last Updated: 2022-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-22

Study Completion Date

2022-03-17

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)

Conditions

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Disinfection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Triple blind - exception of the study team member applying the disinfectant product (intervention)

Study Groups

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Intervention

Application of a 24-hour continuously acting quaternary ammonium salt disinfectant: Sani24 (PDI Healthcare Inc.) by study team

Group Type EXPERIMENTAL

Sani24

Intervention Type OTHER

Disinfectant

Routine Disinfection

Intervention Type OTHER

Routine disinfection at the study hospital

Control

Routine disinfection completed by hospital staff

Group Type ACTIVE_COMPARATOR

Routine Disinfection

Intervention Type OTHER

Routine disinfection at the study hospital

Interventions

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Sani24

Disinfectant

Intervention Type OTHER

Routine Disinfection

Routine disinfection at the study hospital

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Inpatient rooms housing adult patients on contact precautions

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PDI Healthcare Inc.

UNKNOWN

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nick Turner, MD

Role: PRINCIPAL_INVESTIGATOR

Duke School of Medicine

Locations

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Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36378308 (View on PubMed)

Other Identifiers

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Pro00103576

Identifier Type: -

Identifier Source: org_study_id

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