Clinical trial NCT05522725: The Impact of Bedside Wipes in Multi-patient Rooms: a Prospective, Crossover Trial Evaluating Infections and Survival
Official title: The Use of Clinell Universal Wipes, Clinell Sporicidal Wipes, and Clinell EvaluClean Fluorescent Marker System, in Reducing Environmental Contamination and Acquisitions of Multidrug Resistant Organisms and Hospital Acquired Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospital Acquired Infection
Keywords: Hospital Environment
MDRO
Multidrug resistant
Nosocomial infections
Cleaning Practices
High-touch surfaces
HAI
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Gama Healthcare Ltd.
First posted: 2022-08-31
Enrollment: 7725
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: We conducted a clustered crossover trial at Shamir medical center from October 20, 2016 to January 19, 2018. Clusters were randomly assigned to use either single-use quaternary ammonium-based wipes (Clinell®; Watford, UK) or standard practices (reusable cloths, buckets and bleach (hypochlorite 1,000-5,000 ppm)) for cleaning of high-touch surfaces. Six-month intervention periods were implemented in alternating sequence, separated by a 4-week washout period. Five high-touch surfaces were monitored by fluorescent markers (EvaluClean®; Watford, UK), and for the presence of MDRO. Study outcomes were compared between periods using generalized estimating equations, Poisson regression and Cox proportional hazards models.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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).

1. Pre-study period: all rooms will be cleaned daily according to "common practice" which consists of using hypochlorite in a concentration of 1000 ppm (bleach) and reused cloths. The immediate environment (i.e., the 'patient's unit') of those with C. difficile carriage will be cleaned daily with hypochlorite 2000 ppm and upon discharge with hypochlorite 5000 ppm. This is the current "common practice" at AHMC.
2. Phase I: medicine A and B: high touch surfaces (e.g., bedrail, bedside tables, monitor, and cables) will be cleaned with Clinell® Universal Wipes, and the patient's unit of C. difficile carriers will be cleaned with Clinell® Sporicidal Wipes. The floor, walls, and sink, will still be cleaned with bleach. Medicine C and D: all rooms will be cleaned daily according to "common practice" as mentioned above.
3. Washout period in all Medicine departments A, B, C and D: all rooms will be cleaned daily according to "common practice" as mentioned above.
4. Phase II: medicine A and B: all rooms will be cleaned daily according to "common practice" as mentioned above. Medicine C and D: high touch surfaces (bedrail, bedside tables, monitor, cables) will be cleaned with Clinell® Universal Wipes, and the patient's unit of C. difficile carriers will be cleaned with Clinell® Sporicidal Wipes. The floor, walls, and sink, will still be cleaned with bleach.
5. Post-study period: all rooms will be cleaned daily according to "common practice" as mentioned above.

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.

1. MRSA, VRE, A. baumannii, and P. aeruginosa will be determined according to a Vitek-2 automated system and according to CLSI breakpoints and criteria.
2. CRE-CP and CRE non-CP will be determined according to the Israeli MOH national diagnostic guidelines (2013) and based, again, on CLSI criteria.
3. Toxin-producing C. difficile will be determined based of a GDH-based serology test (C. DIFF QUIK CHEK COMPLETE®; Alere™) and if necessary (i.e., inconclusive serology test result: positive for C. difficile GDH antigen but negative for C. difficile toxins), will be confirmed by a PCR-based test (Xpert® C. difficile; Cepheid©). Samples will be processed according to national Israeli guidelines (2013) and according to CLSI criteria.
4. All MDROs will be stored in -700C for future molecular analyses

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).

Eligibility criteria: Inclusion Criteria:

* Hospitalized at one of four Medicine departments at Assaf Harofeh Medical Center: Medicine A, Medicine B, Medicine C, or Medicine D.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Device-related HAI rates
timeFrame: 12 months
Secondary outcomes:
measure: Frequency of cleaning
timeFrame: 12 months
measure: MDRO environmental contamination
timeFrame: 12 months
measure: New MDRO acquisitions
timeFrame: 12 months
measure: In-hospital mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: Be'er Ya'aqov
country: Israel
facility: Shamir Medical Center (Assaf Harofeh)
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Dror Marchaim, MD
role: PRINCIPAL_INVESTIGATOR
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