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Gown and Glove Use to Prevent the Spread of Infection in VA Community Living Centers

Gown and Glove Use to Prevent the Spread of Infection in VA Community Living Centers

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01350479
Enrollment
203
Registered
2011-05-09
Start date
2012-10-01
Completion date
2016-11-01
Last updated
2017-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methicillin-Resistant Staphylococcus Aureus

Keywords

Cross infection, Long term care

Brief summary

Methicillin-resistant S. aureus (MRSA) infections are a common cause of morbidity and mortality in nursing home residents. MRSA is predominantly spread from patient-to-patient by health care workers. The use of gowns, gloves and hand washing prevents this spread; however, their use detracts from a patient-centered, home-like environment which is an important priority for nursing homes. The goal of this project is to determine when it is most important for health care workers to wear gowns and to wash their hands when caring for MRSA colonized Veterans in community living centers.

Detailed description

Methicillin-resistant S. aureus (MRSA) infections are a common cause of morbidity and mortality in nursing home residents. MRSA is predominantly spread from patient-to-patient by health care workers. The use of gowns, gloves and hand washing prevents this spread; however, their use detracts from a patient-centered, home-like environment which is an important priority for nursing homes. The goal of this project is to determine when it is most important for health care workers to wear gowns and to wash their hands when caring for MRSA colonized Veterans in community living centers. To meet this goal, the investigators will enroll \ 400 MRSA-colonized residents and health care workers from VA community living centers in four states and the District of Columbia. Additionally, the investigators will enroll some non-MRSA colonized residents as control subjects. Each enrolled resident will be followed for 6-25 episodes of care observations over 30 days. During each observation, the investigators will have health care workers wear disposable gowns and gloves during each care activity (e.g. wound dressing) that occurs during the study visit. At the end of each care activity, the investigators will swab the gown and gloves prior to disposing of them. Each swab will be tested for MRSA to determine if MRSA from the resident was transferred to the healthcare worker's gown or gloves during that episode of care. The results of the investigators' analysis will be used to develop new infection control guidelines which balance patient safety and a home-like, patient-centered environment.

Interventions

None listed

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Resident: * Age 18 years * Reside in a participating LTCF for rehabilitation, skilled nursing or maintenance care * Expected length of stay of \>4 weeks from enrollment * Written informed consent from participant, or written informed consent from legally authorized representative (LAR) with assent from participant Health Care Worker: * Has direct interaction with participating residents at participating VA Long Term Care Facility (LTCF) * Verbal informed consent

Exclusion criteria

Residents: * None Health Care Worker: * Unable or unwilling to wear protective gown or gloves during healthcare workers (HCW)-resident interaction

Design outcomes

Primary

MeasureTime frameDescription
MRSA TransmissionWill be measured during 6-25 episodes of care interactions scheduled over the 30 days following resident enrollmentPresence of MRSA on gown or gloves worn by enrolled health care worker for research purposes while providing a specific type of care for enrolled resident

Countries

United States

Participant flow

Pre-assignment details

Three participants withdrew from the study prior to cultures being obtained and were not assigned to a study group.

Participants by arm

ArmCount
MRSA Colonized
Residents colonized with MRSA by culture at study admission
94
Not MRSA Colonized
Residents not colonized with MRSA by culture at study admission
106
Total200

Baseline characteristics

CharacteristicMRSA ColonizedNot MRSA ColonizedTotal
Age, Continuous73 years
STANDARD_DEVIATION 13
70 years
STANDARD_DEVIATION 13
71 years
STANDARD_DEVIATION 13
Region of Enrollment
United States
94 participants106 participants200 participants
Sex: Female, Male
Female
2 Participants6 Participants8 Participants
Sex: Female, Male
Male
92 Participants100 Participants192 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
9 / 948 / 106

Outcome results

Primary

MRSA Transmission

Presence of MRSA on gown or gloves worn by enrolled health care worker for research purposes while providing a specific type of care for enrolled resident

Time frame: Will be measured during 6-25 episodes of care interactions scheduled over the 30 days following resident enrollment

Population: We analyzed the number of gown and glove swabs from HCW interacting with MRSA and non-MRSA colonized residents.

ArmMeasureGroupValue (NUMBER)
Swabs From Interactions With MRSA Colonized ResidentsMRSA TransmissionProportion of glove swabs with MRSA0.20 Proportion of swabs positive for MRSA
Swabs From Interactions With MRSA Colonized ResidentsMRSA TransmissionProportion of gown swabs with MRSA0.11 Proportion of swabs positive for MRSA
Swabs From Interactions With Not MRSA Colonized ResidentsMRSA TransmissionProportion of gown swabs with MRSA0.01 Proportion of swabs positive for MRSA
Swabs From Interactions With Not MRSA Colonized ResidentsMRSA TransmissionProportion of glove swabs with MRSA0.02 Proportion of swabs positive for MRSA

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026