Transmission, Other/MiscellaneousNCT04935892
Slippers to Reduce Transfer From Floors to Surfaces
A study testing Slippers in people with Transmission, Other/Miscellaneous, run by Louis Stokes VA Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transmission, Other/Miscellaneous
- What is being tested?
- Slippers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 20 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients of 18 years of age or older
- Ambulatory
- Able to demonstrate an understanding of study procedures
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Wearing Slippers on Transfer of Bacteriophage MS2 From Floors in Patient Rooms to Bedding and Surfaces
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.
Read the 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.
- Conditions
- Transmission, Other/Miscellaneous
- Being tested
- Slippers
- Keywords
- Floor, Bacteriophage MS2, Contamination, Environment, Healthcare-associated pathogens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SlippersBehavioural
Patients in the intervention group wear slippers when out of bed
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Slippers |
| Control | No intervention | Patients receive standard care with no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contamination of a composite of high-touch surfaces, personal items, socks/feet, bedding, and hands
Cultures for MS2
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 Aug 2020
- Primary completion20 Apr 2021
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transmission, Other/MiscellaneousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louis Stokes VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Dr. Curtis Donskey, Louis Stokes VA Medical Center
- Investigators
- Curtis J Donskey, MD, Principal investigator, Cleveland VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935892
- Sponsor's protocol ID
- 17044-H34
- Status last verified
- Jun 2021
- First submitted
- 12 Jun 2021
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will provide de-identified individual participant data to those who provide a request in writing.
Publications
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.
PubMed 35997135
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Wearing Slippers on Transfer of Bacteriophage MS2 From Floors in Patient Rooms to Bedding and Surfaces
- ClinicalTrials.gov ID
- NCT04935892
- Acronym / sponsor ID
- 17044-H34
- Conditions
- Transmission, Other/Miscellaneous
- Keywords
- Floor, Bacteriophage MS2, Contamination, Environment, Healthcare-associated pathogens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Louis Stokes VA Medical CenterUS federal agency
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized trial
| Arm | Type | Receives |
|---|---|---|
| Slippers | Experimental | Behavioral: SlippersPatients wear slippers any time they are out of bed with a goal of avoiding any contact between socks/feet and the floor |
| Control | No intervention | –Patients receive standard care with no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients of 18 years of age or older
- Ambulatory
- Able to demonstrate an understanding of study procedures
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SlippersPatients in the intervention group wear slippers when out of bed | Behavioural | Slippers |
Primary outcome
Contamination of a composite of high-touch surfaces, personal items, socks/feet, bedding, and hands
Time frame: 48 hours
Cultures for MS2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Derived from this study: PubMed 35997135Haq 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.
- Individual participant dataSharing planned: Yes. We will provide de-identified individual participant data to those who provide a request in writing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Curtis J Donskey, MD principal investigator
Cleveland VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slippers in people with Transmission, Other/Miscellaneous, run by Louis Stokes VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contamination of a composite of high-touch surfaces, personal items, socks/feet, bedding, and hands (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04935892, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.