NCT04935892

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
Last Updated

June 25, 2021

Status Verified

June 1, 2021

Enrollment Period

9 months

First QC Date

June 12, 2021

Last Update Submit

June 24, 2021

Conditions

Keywords

FloorBacteriophage MS2ContaminationEnvironmentHealthcare-associated pathogens

Outcome Measures

Primary Outcomes (1)

  • Contamination of a composite of high-touch surfaces, personal items, socks/feet, bedding, and hands

    Cultures for MS2

    48 hours

Study Arms (2)

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

SlippersBEHAVIORAL

Patients in the intervention group wear slippers when out of bed

Slippers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland VA Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Curtis J Donskey, MD

    Cleveland VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Lab personnel processing cultures blinded to the study group
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized trial
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 12, 2021

First Posted

June 23, 2021

Study Start

August 1, 2020

Primary Completion

April 20, 2021

Study Completion

April 20, 2021

Last Updated

June 25, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

We will provide de-identified individual participant data to those who provide a request in writing.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Available 6/22/21 through 6/22/24
Access Criteria
Written request

Locations