Slippers to Reduce Transfer From Floors to Surfaces | NCT04935892

Studies
Slippers to Reduce Transfer From Floors to Surfaces

NCT04935892

Sponsor

Louis Stokes VA Medical Center

Status

Completed

Last Update Posted

Jun 25, 2021Actual

Enrollment

34Actual

Phase

Not Applicable

Conditions

Transmission, Other/Miscellaneous

Interventions

Slippers

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Actual

Primary Completion Date

Apr 20, 2021Actual

Completion Date

Apr 20, 2021Actual

First Submitted Date

Jun 12, 2021

First Submission Date that Met QC Criteria

Jun 12, 2021

First Posted Date

Jun 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2021

Last Update Posted Date

Jun 25, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Curtis Donskey, Principal Investigator, Louis Stokes VA Medical CenterPrincipal Investigator

Lead Sponsor

Louis Stokes VA Medical CenterFED

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this study is to determine if wearing slippers will reduce transfer of bacteriophage MS2 from hospital room floors to surfaces in the room and hands of patients. Subjects are randomized to wear slippers versus standard care and cultures are collected at 24 and 48 hours to assess transfer of bacteriophage MS2 from the floor to high-touch surfaces, personal items, bedding, socks or feet, and hands of patients.

Detailed Description

The goal of this study is to determine if wearing slippers will reduce transfer of bacteriophage MS2 from hospital room floors to surfaces in the room and hands of patients. Hospitalized patients are enrolled and randomized to wear slippers any time they are out of bed versus standard care. Bacteriophage MS2 is inoculated onto a site on the floor between the patient bed and the bathroom. Cultures are collected at 24 and 48 hours to assess transfer of bacteriophage MS2 from the floor to high-touch surfaces (bed rail, bedside table, telephone, call button), personal items, bedding, socks or feet, and hands of patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Slippers	Experimental	Patients wear slippers any time they are out of bed with a goal of avoiding any contact between socks/feet and the floor	Behavioral: Slippers
Control	No Intervention	Patients receive standard care with no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Slippers	Behavioral	Patients in the intervention group wear slippers when out of bed	Slippers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Contamination of a composite of high-touch surfaces, personal items, socks/feet, bedding, and hands	Cultures for MS2	48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients of 18 years of age or older
Ambulatory
Able to demonstrate an understanding of study procedures

Exclusion Criteria:

Unable or unwilling to fulfill study requirements.
Expected length of stay less than 48 hours
Any patient deemed not suitable for study participation at the discretion of the study investigator

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Curtis J Donskey, MD	Cleveland VA Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland VA Medical Center		Cleveland	Ohio	44106	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35997135	Derived	Haq MF, Alhmidi H, Redmond SN, Cadnum JL, Silva SY, Wilson BM, Donskey CJ. A randomized trial to determine whether wearing slippers reduces transfer of bacteriophage MS2 from floors to patients and surfaces in hospital rooms. Infect Control Hosp Epidemiol. 2023 Apr;44(4):670-673. doi: 10.1017/ice.2021.475. Epub 2022 Aug 23.