NCT01481935

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
6 months until next milestone

Results Posted

Study results publicly available

October 19, 2012

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

9 months

First QC Date

November 21, 2011

Results QC Date

September 19, 2012

Last Update Submit

February 15, 2022

Conditions

Keywords

Antibiotic resistant bacteriaColonizationHospital cleaningEnvironmental cleaningInfection Control

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Enhanced Cleaning

EXPERIMENTAL

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

Sham Enhanced Cleaning

SHAM COMPARATOR

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

Interventions

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
Enhanced 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
Sham Enhanced Cleaning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Room is occupied by a patient who occupied another room at the time it was enrolled and followed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21230, United States

Location

Related Publications (8)

  • 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. doi: 10.1016/j.jhin.2007.09.015. Epub 2007 Dec 11.

    PMID: 18069083BACKGROUND
  • 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.

    PMID: 18624666BACKGROUND
  • 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.

    PMID: 20486855BACKGROUND
  • 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.

    PMID: 20569855BACKGROUND
  • 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.

    PMID: 9309433BACKGROUND
  • 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.

    PMID: 18549314BACKGROUND
  • 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.

    PMID: 21242793BACKGROUND
  • Hess AS, Shardell M, Johnson JK, Thom KA, Roghmann MC, Netzer G, Amr S, Morgan DJ, Harris AD. A randomized controlled trial of enhanced cleaning to reduce contamination of healthcare worker gowns and gloves with multidrug-resistant bacteria. Infect Control Hosp Epidemiol. 2013 May;34(5):487-93. doi: 10.1086/670205.

Results Point of Contact

Title
Anthony D. Harris, MD MPH
Organization
University of Maryland School of Medicine

Study Officials

  • Anthony D Harris, MD MPH

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Epidemiology and Public Health

Study Record Dates

First Submitted

November 21, 2011

First Posted

November 30, 2011

Study Start

August 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

February 16, 2022

Results First Posted

October 19, 2012

Record last verified: 2022-02

Locations