The Impact of Bedside Wipes in Multi-patient Rooms: a Prospective, Crossover Trial Evaluating Infections and Survival

NCT ID: NCT05522725

Last Updated: 2022-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7725 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-20
• Study Completion Date: 2018-01-19

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).

Conditions

Hospital Acquired Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION

Study Groups

Intervention phase

Single-use wipes installed at the bedside

Group Type: EXPERIMENTAL

Single-use wipes installed at the bedside

Intervention Type: OTHER

Non-intervention phase

Standard practice according to Israeli ministry of health (MOH)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Single-use wipes installed at the bedside

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gama Healthcare Ltd.

INDUSTRY

Sponsor Role: collaborator

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dror Marchaim, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf-Harofeh Medical Center

Locations

Shamir Medical Center (Assaf Harofeh)

Be’er Ya‘aqov, , Israel

Countries

Israel

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Other Identifiers

124-16-ASF

Identifier Type: -

Identifier Source: org_study_id