An interventional study of Enhanced cleaning of surfaces in ICU rooms and Sham enhanced cleaning of surfaces in ICU rooms in Infection Control, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-16.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Other
The purpose of this study is to determine whether extra cleaning of frequently-contaminated surfaces in intensive care rooms is effective in preventing contamination of disposable isolation gowns and gloves with multi-drug resistant bacteria.
Hospital infections are often caused by bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) or multi-drug-resistant Acinetobacter baumannii (MDRAB). Hospital infections increase the cost of health care, length of hospital stay, and mortality compared to infections with antibiotic-susceptible organisms. Many of these antibiotic-resistant bacteria are transmitted by patient-to-patient contact.
Healthcare workers are one possible vector of patient-to-patient transmission. Transient colonization of hands, clothing and protective equipment can leads to the colonization and infection of other patients. The surfaces of patient rooms are also frequently contaminated with antibiotic-resistant bacteria. A number of recent studies have concluded that patient rooms are not cleaned thoroughly or frequently enough to keep commonly touched surfaces free of bacterial contamination. Given the frequency of contact between the healthcare worker and the patient's environment, bacteria that contaminate environmental surfaces while the patient is in the room are a significant potential reservoir for patient-to-patient transmission via the hands of healthcare workers.
In this study, the investigators will examine rooms of intensive care unit patients colonized with MRSA or MDRAB. The investigators will randomize these rooms to receive either standard room cleaning plus a cleaning of high-touch surfaces ('enhanced cleaning') or to receive only standard room cleaning plus a sham cleaning of high-touch surfaces ('sham enhanced cleaning'). The investigators will then culture healthcare workers' disposable isolation gowns and gloves as they exit the enrolled room after routine patient care activities. The investigators will examine the cultures for the presence of MRSA or MDRAB to determine whether additional cleaning significantly reduces the proportion of healthcare workers with contaminated gloves and gowns, and therefore may reduce the risk of transmitting these bacteria to other patients. The results of this trial will help guide future efforts to decrease patient-to-patient transmission of antibiotic-resistant bacteria.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 190 is above the median of 120 across 4,200 interventional studies indexed under Infections.
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Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
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Exclusion Criteria:
Rooms in the Enhanced Cleaning arm will receive cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff.
Other: Enhanced cleaning of surfaces in ICU rooms
Rooms in the Sham Enhanced Cleaning arm will receive a sham cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff.
Other: Sham enhanced cleaning of surfaces in ICU rooms
Using a paper towel pre-soaked with a commercially-available quaternary ammonium cleaning solution (Virex WetTask wipes, Kimberly-Clark, Irving, Texas), the following surfaces will be wiped clean by a study investigator if present: bed rail top bar, bed electronic control surfaces, moveable tray table top and control surfaces desktop and sides, IV poles, infusion pump control surfaces, nurse call button, patient telephone/remote control, sink console top, light switches and plates, supply cart top and drawer handles, ventilator control surfaces and desk, vital signs monitor control surfaces. Cleaning will occur once on the day of enrollment and follow-up.
Also known as: Environmental cleaning
While holding a paper towel pre-soaked with a commercially-available quaternary ammonium cleaning solution (Virex WetTask wipes, Kimberly-Clark, Irving, Texas), a study investigator will mime the action of wiping the following surfaces in the room clean if present: bed rail top bar, bed electronic control surfaces, moveable tray table top and control surfaces desktop and sides, IV poles, infusion pump control surfaces, nurse call button, patient telephone/remote control, sink console top, light switches and plates, supply cart top and drawer handles, ventilator control surfaces and desk, vital signs monitor control surfaces. The sham cleaning will occur once on the day of enrollment and follow-up.
Also known as: Sham Environmental Cleaning
Contamination of Disposable Isolation Gown and Gloves With Methicillin-resistant Staphylococcus Aureus or Multi-drug-resistant Acinetobacter Baumannii
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.
Time frame: As a healthcare worker exits the enrolled room (1 day)
Rooms in 4 ICUs in a large, urban, academic hospital. Recruitment began on 7/21/2011 and ended on 5/20/2012.
| Milestone | Sham Enhanced Cleaning | Enhanced Cleaning |
|---|---|---|
| Started | 97 | 93 |
| Completed | 97 | 93 |
| Not completed | 0 | 0 |
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.
| percentage of positive cultures | Sham Enhanced Cleaning | Enhanced Cleaning |
|---|---|---|
| Contamination of Disposable Isolation Gown and Gloves With Methicillin-resistant Staphylococcus Aureus or Multi-drug-resistant Acinetobacter Baumannii | 20.5 ± 2.1 | 17.2 ± 2.5 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sham Enhanced Cleaning | — | 0/97 (0%) | 0/97 (0%) |
| Enhanced Cleaning | — | 0/93 (0%) | 0/93 (0%) |
| Age, Categorical(Participants) | Enhanced Cleaning | Sham Enhanced Cleaning | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 66 | 66 | 132 |
| >=65 years | 27 | 31 | 58 |
| Age, Continuous(years) | Enhanced Cleaning | Sham Enhanced Cleaning | Total |
|---|---|---|---|
| Mean | 51 ± 19 | 56 ± 17 | 54 ± 18 |
| Sex: Female, Male(Participants) | Enhanced Cleaning | Sham Enhanced Cleaning | Total |
|---|---|---|---|
| Female | 30 | 41 | 71 |
| Male | 63 | 56 | 119 |
| Region of Enrollment(participants) | Enhanced Cleaning | Sham Enhanced Cleaning | Total |
|---|---|---|---|
| United States | 93 | 97 | 190 |
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore