An interventional study of Single-use wipes installed at the bedside in Hospital Acquired Infection, sponsored by Assaf-Harofeh Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-02.
Sponsored by Assaf-Harofeh Medical Center · Not applicable, Interventional, and Prevention
Multidrug resistant organisms (MDRO) are prevalent in hospitals and are associated with hospital-acquired infections (HAI). High-touch surfaces serve as reservoirs and fomites for MDRO transmission. The investigators quantified the impact of hanging single-use cleaning/disinfecting wipes in patients' immediate environment within multi-patient rooms. Pre-specified outcomes were: 1) HAI rate, 2) cleaning frequency, 3) MDRO room contamination, 4) new MDRO acquisitions, and 5) in-hospital mortality.
The study will be conducted over 15 months; each study phase will last 6 months, with a pre-study period (1 month), a washout period (1 month) and a post study period (1 month).
During the intervention phase, the whole department will be subjected to the intervention, regardless of the number of MDRO carriers present on the department (i.e. signifying the "colonization pressure" at the department). "Colonization pressure" will be continuously captured and recorded for future analyses.
All departments will perform, per local Infection Control regulations, rectal surveillance cultures upon admission to the department, to diagnose VRE, CRE-CP, and CRE-non-CP from certain populations: 1) patients directly transferred from another hospital; 2) patients directly transferred from another department inside AHMC; 3) functionally dependent patients (per Katz criteria); 4) residents of long-term care facilities; 5) patients who were hospitalized in an acute care hospital in the past six months; and 6) prisoners. In addition, every department selects one day per week for screening (rectally again) of 10 additional patients who are already hospitalized, but belong to high risk population for VRE and/or CRE colonization. In addition, once a week, a sputum screening culture for the presence of A. baumannii is obtained from all mechanically ventilated patients. No other surveillance cultures are performed in those Medicine departments, except theoretically as part of an outbreak investigation. The median departmental occupancy of all participating departments is 45 patients (the median number of mechanically ventilated patients in each department is 5). The patients' mix in all participating departments is equal, and patients are hospitalized in a certain department randomly. The departments are equal in structure, in the number of patients, and in its patients' characteristics.
All the surveillance for HAI determination and MDRO acquisitions are conducted routinely and continuously by the Infection Control team at AHMC. The primary investigator of this proposal serves as the head of Infection Control service and therefore is personally involved in the surveillances processes for those endpoints.
Frequency of cleaning will be assessed by Clinell® EvaluClean™ fluorescent marker system twice a week, on Mondays and Thursdays morning until afternoon, in all participating departments throughout the study period. The assessment will include the marking of five locations at a patient unit from each participating department, and the examination of the marks 4 hours later. The five location points are: 1) right bedrail, 2) the tray of the bedside table, 3) the binder that contains the fluid balance pages, hanging at the foot of the bed, 4) Strip for delivery and storage at the headboard of each bed, and 5) the bed itself.
Since the 4 study units are all identical in structure (in terms of room numbers and bed numbers), the patient units that will be randomly selected every week will be compatible. For example, in the first week, the patient units that could be randomly selected will be bed number 2 in room number 9 and bed number 1 in room number 2, in all 4-study units.
Clinical cultures are all processed at the AHMC clinical microbiology laboratory. No additional cultures will be obtained specifically for this protocol.
Representative MDROs will be typed later on for future detailed transmission dynamics investigations.
The laboratory will be blinded to the source of the cultures (i.e., the study department and study phase).
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 7,725 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Assaf-Harofeh Medical Center is the lead sponsor of 258 studies on the registry; 40 are open to participants now.
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Exclusion Criteria:
Single-use wipes installed at the bedside
Other: Single-use wipes installed at the bedside
Standard practice according to Israeli ministry of health (MOH)
Device-related HAI rates
Central line associated bloodstream infections (CLABSI) and catheter-associated urinary tract infections (CAUTI), monitored in accordance to CDC criteria
Time frame: 12 months
Frequency of cleaning
Invisible fluorescent marks at the patient unit will be examined to assess whether the location has been cleaned or not, using Clinell® EvaluClean™ fluorescent marker system. The endpoint would be presented as percents of adherence (i.e., the number of locations cleaned, divided by the overall number of locations what were marked).
Time frame: 12 months
MDRO environmental contamination
Environmental contamination measurements of MDRO were performed for all patients with a current or recent (prior two years) culture of MRSA, VRE, CRE, A. baumannii, or P. aeruginosa.
Time frame: 12 months
New MDRO acquisitions
MDRO included methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), carbapenemase-producing and non-carbapenemase-producing carbapenem-resistant Enterobacterales (CRE-CP and CRE-non-CP, respectively), and non-lactose fermenting Gram-negative bacilli (Acinetobacter baumannii, Pseudomonas aeruginosa)
Time frame: 12 months
In-hospital mortality
In-hospital mortality was collected from medical charts. The endpoint is defined as the proportion of patients with in-hospital deaths during the measurement period.
Time frame: 12 months
Plan to share: No
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Assaf-Harofeh Medical Center