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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01481935
Other study ID # HP-00048554
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2011
Est. completion date May 2012

Study information

Verified date February 2022
Source University of Maryland, Baltimore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 190
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Room is occupied by a patient colonized with methicillin-resistant Staphylococcus aureus and/or multi-drug-resistant Acinetobacter baumannii - Occupant of the room is on contact precautions - Occupant was admitted to the room at least 24 hours prior to the time of screening Exclusion Criteria: - Room is occupied by a patient who occupied another room at the time it was enrolled and followed.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.
Sham enhanced cleaning of surfaces in ICU rooms
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.

Locations

Country Name City State
United States University of Maryland, Baltimore Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (7)

Boyce JM, Potter-Bynoe G, Chenevert C, King T. Environmental contamination due to methicillin-resistant Staphylococcus aureus: possible infection control implications. Infect Control Hosp Epidemiol. 1997 Sep;18(9):622-7. — View Citation

Carling PC, Bartley JM. Evaluating hygienic cleaning in health care settings: what you do not know can harm your patients. Am J Infect Control. 2010 Jun;38(5 Suppl 1):S41-50. doi: 10.1016/j.ajic.2010.03.004. Review. — View Citation

Carling PC, Von Beheren S, Kim P, Woods C; Healthcare Environmental Hygiene Study Group. Intensive care unit environmental cleaning: an evaluation in sixteen hospitals using a novel assessment tool. J Hosp Infect. 2008 Jan;68(1):39-44. Epub 2007 Dec 11. — View Citation

Goodman ER, Platt R, Bass R, Onderdonk AB, Yokoe DS, Huang SS. Impact of an environmental cleaning intervention on the presence of methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococci on surfaces in intensive care unit rooms. Infect Control Hosp Epidemiol. 2008 Jul;29(7):593-9. doi: 10.1086/588566. — View Citation

Morgan DJ, Liang SY, Smith CL, Johnson JK, Harris AD, Furuno JP, Thom KA, Snyder GM, Day HR, Perencevich EN. Frequent multidrug-resistant Acinetobacter baumannii contamination of gloves, gowns, and hands of healthcare workers. Infect Control Hosp Epidemiol. 2010 Jul;31(7):716-21. doi: 10.1086/653201. — View Citation

Snyder GM, Thom KA, Furuno JP, Perencevich EN, Roghmann MC, Strauss SM, Netzer G, Harris AD. Detection of methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococci on the gowns and gloves of healthcare workers. Infect Control Hosp Epidemiol. 2008 Jul;29(7):583-9. doi: 10.1086/588701. — View Citation

Wilson AP, Smyth D, Moore G, Singleton J, Jackson R, Gant V, Jeanes A, Shaw S, James E, Cooper B, Kafatos G, Cookson B, Singer M, Bellingan G. The impact of enhanced cleaning within the intensive care unit on contamination of the near-patient environment with hospital pathogens: a randomized crossover study in critical care units in two hospitals. Crit Care Med. 2011 Apr;39(4):651-8. doi: 10.1097/CCM.0b013e318206bc66. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. As a healthcare worker exits the enrolled room (1 day)
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