Trial Outcomes & Findings for Gown and Glove Use to Prevent the Spread of Infection in VA Community Living Centers (NCT NCT01350479)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

203 participants

Primary outcome timeframe

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

Results posted on

2017-10-05

Participant Flow

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

Participant milestones

Participant milestones
Measure	MRSA Colonized Residents colonized with MRSA by culture at study admission	Not MRSA Colonized Residents not colonized with MRSA by culture at study admission
Overall Study STARTED	94	106
Overall Study COMPLETED	94	106
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MRSA Colonized n=94 Participants Residents colonized with MRSA by culture at study admission	Not MRSA Colonized n=106 Participants Residents not colonized with MRSA by culture at study admission	Total n=200 Participants Total of all reporting groups
Age, Continuous	73 years STANDARD_DEVIATION 13 • n=5 Participants	70 years STANDARD_DEVIATION 13 • n=7 Participants	71 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	92 Participants n=5 Participants	100 Participants n=7 Participants	192 Participants n=5 Participants
Region of Enrollment United States	94 participants n=5 Participants	106 participants n=7 Participants	200 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Swabs From Interactions With MRSA Colonized Residents n=1543 swabs Swabs collected from healthcare workers interacting with residents colonized with MRSA by culture on enrollment	Swabs From Interactions With Not MRSA Colonized Residents n=1462 swabs Swabs collected from healthcare workers interacting with residents not colonized with MRSA by culture on enrollment
MRSA Transmission Proportion of gown swabs with MRSA	0.11 Proportion of swabs positive for MRSA	0.01 Proportion of swabs positive for MRSA
MRSA Transmission Proportion of glove swabs with MRSA	0.20 Proportion of swabs positive for MRSA	0.02 Proportion of swabs positive for MRSA

Adverse Events

MRSA Colonized

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Not MRSA Colonized

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MRSA Colonized n=94 participants at risk Residents colonized with MRSA by culture at study admission	Not MRSA Colonized n=106 participants at risk Residents not colonized with MRSA by culture at study admission
General disorders Hospitalization	9.6% 9/94 Only serious adverse events were collected.	5.7% 6/106 Only serious adverse events were collected.
General disorders Death	0.00% 0/94 Only serious adverse events were collected.	1.9% 2/106 Only serious adverse events were collected.

Other adverse events

Adverse event data not reported

Additional Information

Mary-Claire Roghmann

VA Maryland Healthcare System

Phone: 410-706-0062

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place