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

NCT05522725 | Completed

• 1 other identifier: 124-16-ASF
• Study Type: interventional
• Target: 7,725
• Locations: 1 country
• Sites: 1

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.

Conditions

Hospital Acquired Infection

Keywords

Hospital Environment; MDRO; Multidrug resistant; Nosocomial infections; Cleaning Practices; High-touch surfaces; HAI

Outcome Measures

Primary Outcomes (1)

• Device-related HAI rates

  Central line associated bloodstream infections (CLABSI) and catheter-associated urinary tract infections (CAUTI), monitored in accordance to CDC criteria

  12 months

Secondary Outcomes (4)

• Frequency of cleaning

  12 months

• MDRO environmental contamination

  12 months

• New MDRO acquisitions

  12 months

• In-hospital mortality

  12 months

Study Arms (2)

Intervention phase

EXPERIMENTAL

Single-use wipes installed at the bedside

Other: Single-use wipes installed at the bedside

Non-intervention phase

NO INTERVENTION

Standard practice according to Israeli ministry of health (MOH)

Interventions

Single-use wipes installed at the bedside OTHER

Intervention phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead
• Gama Healthcare Ltd.: collaborator

Study Sites (1)

Shamir Medical Center (Assaf Harofeh)

Be’er Ya‘aqov, 70300, Israel

Location

Related Publications (17)

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  PMID: 20569853 BACKGROUND

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• Boyce JM. Modern technologies for improving cleaning and disinfection of environmental surfaces in hospitals. Antimicrob Resist Infect Control. 2016 Apr 11;5:10. doi: 10.1186/s13756-016-0111-x. eCollection 2016.

  PMID: 27069623 BACKGROUND

• Han JH, Sullivan N, Leas BF, Pegues DA, Kaczmarek JL, Umscheid CA. Cleaning Hospital Room Surfaces to Prevent Health Care-Associated Infections: A Technical Brief. Ann Intern Med. 2015 Oct 20;163(8):598-607. doi: 10.7326/M15-1192. Epub 2015 Aug 11.

  PMID: 26258903 BACKGROUND

• Martin ET, Haider S, Palleschi M, Eagle S, Crisostomo DV, Haddox P, Harmon L, Mazur R, Moshos J, Marchaim D, Kaye KS. Bathing hospitalized dependent patients with prepackaged disposable washcloths instead of traditional bath basins: A case-crossover study. Am J Infect Control. 2017 Sep 1;45(9):990-994. doi: 10.1016/j.ajic.2017.03.023. Epub 2017 May 11.

  PMID: 28502637 BACKGROUND

• The Israeli Ministry of Health Manual 2006.

  BACKGROUND

• Marchaim D, Taylor AR, Hayakawa K, Bheemreddy S, Sunkara B, Moshos J, Chopra T, Abreu-Lanfranco O, Martin ET, Pogue JM, Lephart PR, Panda S, Dhar S, Kaye KS. Hospital bath basins are frequently contaminated with multidrug-resistant human pathogens. Am J Infect Control. 2012 Aug;40(6):562-4. doi: 10.1016/j.ajic.2011.07.014. Epub 2011 Dec 16.

  PMID: 22177667 BACKGROUND

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  PMID: 23622759 BACKGROUND

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  PMID: 15754723 BACKGROUND

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  PMID: 18538699 BACKGROUND

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  PMID: 35276310 BACKGROUND

• Zilberman-Itskovich S, Youngster I, Lazarovitch T, Bondarenco M, Toledano L, Kachlon Y, Mengesha B, Strul N, Zaidenstein R, Marchaim D. Potential impact of removing metronidazole from treatment armamentarium of mild acute Clostridioides difficile infection. Future Microbiol. 2019 Nov;14:1489-1495. doi: 10.2217/fmb-2019-0157. Epub 2020 Jan 8.

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• World Health Organization. WHO publishes list of bacteria for which new antibiotics are urgently needed. Published online February 27, 2017

  BACKGROUND

• Leddin D, Omary MB, Veitch A, Metz G, Amrani N, Aabakken L, Raja Ali RA, Alvares-Da-Silva MR, Armstrong D, Boyacioglu S, Chen Y, Elwakil R, Fock KM, Hamid SS, Makharia G, Macrae F, Malekzadeh R, Mulder CJ, Piscoya A, Perman ML, Sadeghi A, Saenz R, Saurin JC, Butt AS, Wu K, Lee YY. Uniting the Global Gastroenterology Community to Meet the Challenge of Climate Change and Non-Recyclable Waste. Gastroenterology. 2021 Nov;161(5):1354-1360. doi: 10.1053/j.gastro.2021.08.001. Epub 2021 Oct 7. No abstract available.

  PMID: 34629165 BACKGROUND

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dror Marchaim, MD

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: August 31, 2022
• Study Start: October 20, 2016
• Primary Completion: December 19, 2017
• Study Completion: January 19, 2018
• Last Updated: September 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)