Trial Outcomes & Findings for Enhanced Room Cleaning in Intensive Care Units to Reduce Gown and Glove Contamination With Multi-drug-resistant Bacteria (NCT NCT01481935)

NCT ID: NCT01481935

Last Updated: 2022-02-16

Results Overview

Swabs will be collected from the disposable gown and gloves of healthcare workers exiting the enrolled room. A single swab will be used for both gloves and the gown. The swab will be assayed for methicillin-resistant Staphylococcus aureus, multi-drug-resistant Acinetobacter baumannii, or both, depending on which organism(s) the occupant of the enrolled room is colonized with. The swab will be considered positive if the relevant organism is isolated. We will sample the first 15 healthcare worker exits after the room has received the allocated intervention.

Recruitment status

COMPLETED

Study phase

Target enrollment

190 participants

Primary outcome timeframe

As a healthcare worker exits the enrolled room (1 day)

Results posted on

2022-02-16

Participant Flow

Rooms in 4 ICUs in a large, urban, academic hospital. Recruitment began on 7/21/2011 and ended on 5/20/2012.

Participant milestones

Participant milestones
Measure	Sham Enhanced Cleaning Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).	Enhanced Cleaning Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
Overall Study STARTED	97	93
Overall Study COMPLETED	97	93
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enhanced Room Cleaning in Intensive Care Units to Reduce Gown and Glove Contamination With Multi-drug-resistant Bacteria

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enhanced Cleaning n=93 Participants Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).	Sham Enhanced Cleaning n=97 Participants Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).	Total n=190 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	66 Participants n=5 Participants	66 Participants n=7 Participants	132 Participants n=5 Participants
Age, Categorical >=65 years	27 Participants n=5 Participants	31 Participants n=7 Participants	58 Participants n=5 Participants
Age, Continuous	51 years STANDARD_DEVIATION 19 • n=5 Participants	56 years STANDARD_DEVIATION 17 • n=7 Participants	54 years STANDARD_DEVIATION 18 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	41 Participants n=7 Participants	71 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	56 Participants n=7 Participants	119 Participants n=5 Participants
Region of Enrollment United States	93 participants n=5 Participants	97 participants n=7 Participants	190 participants n=5 Participants

PRIMARY outcome

Timeframe: As a healthcare worker exits the enrolled room (1 day)

Population: Unit of analysis was the ICU room. Results from multiple participants who occupied a single room over the course of the trial were summarized by room.

Outcome measures

Outcome measures
Measure	Sham Enhanced Cleaning n=55 Rooms Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).	Enhanced Cleaning n=49 Rooms Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
Contamination of Disposable Isolation Gown and Gloves With Methicillin-resistant Staphylococcus Aureus or Multi-drug-resistant Acinetobacter Baumannii	20.5 percentage of positive cultures Standard Error 2.1	17.2 percentage of positive cultures Standard Error 2.5

Adverse Events

Sham Enhanced Cleaning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enhanced Cleaning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anthony D. Harris, MD MPH

University of Maryland School of Medicine

Phone: 410-706-0064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place