Hospital Acquired InfectionNCT05522725
The Impact of Bedside Wipes in Multi-patient Rooms: a Prospective, Crossover Trial Evaluating Infections and Survival
A study testing Single-use wipes installed at the bedside in people with Hospital Acquired Infection, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital Acquired Infection
- What is being tested?
- Single-use wipes installed at the bedside
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,725 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Oct 2016to 19 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized at one of four Medicine departments at Assaf Harofeh Medical Center: Medicine A, Medicine B, Medicine C, or Medicine D.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- 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.
- 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.
- Washout period in all Medicine departments A, B, C and D: all rooms will be cleaned daily according to "common practice" as mentioned above.
- 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.
- 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.
- MRSA, VRE, A. baumannii, and P. aeruginosa will be determined according to a Vitek-2 automated system and according to CLSI breakpoints and criteria.
- CRE-CP and CRE non-CP will be determined according to the Israeli MOH national diagnostic guidelines (2013) and based, again, on CLSI criteria.
- 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.
- 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
- Being tested
- Single-use wipes installed at the bedside
- Keywords
- Hospital Environment, MDRO, Multidrug resistant, Nosocomial infections, Cleaning Practices, High-touch surfaces, HAI
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-use wipes installed at the bedsideOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention phase | Experimental | Single-use wipes installed at the bedside Receives: Other: Single-use wipes installed at the bedside |
| Non-intervention phase | No intervention | Standard practice according to Israeli ministry of health (MOH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-related HAI rates
Central line associated bloodstream infections (CLABSI) and catheter-associated urinary tract infections (CAUTI), monitored in accordance to CDC criteria
Measured: 12 months
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start20 Oct 2016
- Primary completion19 Dec 2017
- Study completion19 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Hospital Acquired InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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.
- Enrolment
- 7,725 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Collaborators
- Gama Healthcare Ltd.
- Responsible party
- Sponsor
- Investigators
- Dror Marchaim, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522725
- Sponsor's protocol ID
- 124-16-ASF
- Status last verified
- Aug 2022
- First submitted
- 28 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weber DJ, Rutala WA, Miller MB, Huslage K, Sickbert-Bennett E. Role of hospital surfaces in the transmission of emerging health care-associated pathogens: norovirus, Clostridium difficile, and Acinetobacter species. Am J Infect Control. 2010 Jun;38(5 Suppl 1):S25-33. doi: 10.1016/j.ajic.2010.04.196.
PubMed 20569853Manoukian S, Stewart S, Graves N, Mason H, Robertson C, Kennedy S, Pan J, Haahr L, Dancer SJ, Cook B, Reilly J. Evaluating the post-discharge cost of healthcare-associated infection in NHS Scotland. J Hosp Infect. 2021 Aug;114:51-58. doi: 10.1016/j.jhin.2020.12.026.
PubMed 34301396Boyce 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.
PubMed 27069623Han 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.
PubMed 26258903Martin 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.
PubMed 28502637The Israeli Ministry of Health Manual 2006.
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.
PubMed 22177667Sattar SA, Maillard JY. The crucial role of wiping in decontamination of high-touch environmental surfaces: review of current status and directions for the future. Am J Infect Control. 2013 May;41(5 Suppl):S97-104. doi: 10.1016/j.ajic.2012.10.032.
PubMed 23622759Baker F, Scott P, Kingsley A. Disposable cleansing wipes. Prof Nurse. 2005 Mar;20(7):45-7.
PubMed 15754723Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available.
PubMed 18538699Smith H, Watkins J, Otis M, Hebden JN, Wright MO. Health care-associated infections studies project: An American journal of infection control and national healthcare safety network data quality collaboration case study - Chapter 2 Identifying Healthcare-associated Infections (HAI) for NHSN Surveillance case study vignettes. Am J Infect Control. 2022 Jun;50(6):695-698. doi: 10.1016/j.ajic.2022.02.028. Epub 2022 Mar 8.
PubMed 35276310Zilberman-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.
PubMed 31913060Austin PC. Absolute risk reductions and numbers needed to treat can be obtained from adjusted survival models for time-to-event outcomes. J Clin Epidemiol. 2010 Jan;63(1):46-55. doi: 10.1016/j.jclinepi.2009.03.012. Epub 2009 Jul 12.
PubMed 19595575Tanner WD, Leecaster MK, Zhang Y, Stratford KM, Mayer J, Visnovsky LD, Alhmidi H, Cadnum JL, Jencson AL, Koganti S, Bennett CP, Donskey CJ, Noble-Wang J, Reddy SC, Rose LJ, Watson L, Ide E, Wipperfurth T, Safdar N, Arasim M, Macke C, Roman P, Krein SL, Loc-Carrillo C, Samore MH. Environmental Contamination of Contact Precaution and Non-Contact Precaution Patient Rooms in Six Acute Care Facilities. Clin Infect Dis. 2021 Jan 29;72(Suppl 1):S8-S16. doi: 10.1093/cid/ciaa1602.
PubMed 33512527Turner RM, White IR, Croudace T; PIP Study Group. Analysis of cluster randomized cross-over trial data: a comparison of methods. Stat Med. 2007 Jan 30;26(2):274-89. doi: 10.1002/sim.2537.
PubMed 16538700
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05522725
- Acronym / sponsor ID
- 124-16-ASF
- Conditions
- Hospital Acquired Infection
- Keywords
- Hospital Environment, MDRO, Multidrug resistant, Nosocomial infections, Cleaning Practices, High-touch surfaces, HAI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,725 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Collaborators
- Gama Healthcare Ltd.
- Study start
- 20 Oct 2016 (actual)
- Primary completion
- 19 Dec 2017 (actual)
- Study completion
- 19 Jan 2018 (actual)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- 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.
- 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.
- Washout period in all Medicine departments A, B, C and D: all rooms will be cleaned daily according to "common practice" as mentioned above.
- 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.
- 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.
- MRSA, VRE, A. baumannii, and P. aeruginosa will be determined according to a Vitek-2 automated system and according to CLSI breakpoints and criteria.
- CRE-CP and CRE non-CP will be determined according to the Israeli MOH national diagnostic guidelines (2013) and based, again, on CLSI criteria.
- 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.
- 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention phase | Experimental | Other: Single-use wipes installed at the bedsideSingle-use wipes installed at the bedside |
| Non-intervention phase | No intervention | –Standard practice according to Israeli ministry of health (MOH) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized at one of four Medicine departments at Assaf Harofeh Medical Center: Medicine A, Medicine B, Medicine C, or Medicine D.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-use wipes installed at the bedside | Other | Intervention phase |
Primary outcome
Device-related HAI rates
Time frame: 12 months
Central line associated bloodstream infections (CLABSI) and catheter-associated urinary tract infections (CAUTI), monitored in accordance to CDC criteria
4 secondary outcomes
Frequency of cleaning
Time frame: 12 months
MDRO environmental contamination
Time frame: 12 months
New MDRO acquisitions
Time frame: 12 months
In-hospital mortality
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Background: PubMed 20569853Weber DJ, Rutala WA, Miller MB, Huslage K, Sickbert-Bennett E. Role of hospital surfaces in the transmission of emerging health care-associated pathogens: norovirus, Clostridium difficile, and Acinetobacter species. Am J Infect Control. 2010 Jun;38(5 Suppl 1):S25-33. doi: 10.1016/j.ajic.2010.04.196.
- Background: PubMed 34301396Manoukian S, Stewart S, Graves N, Mason H, Robertson C, Kennedy S, Pan J, Haahr L, Dancer SJ, Cook B, Reilly J. Evaluating the post-discharge cost of healthcare-associated infection in NHS Scotland. J Hosp Infect. 2021 Aug;114:51-58. doi: 10.1016/j.jhin.2020.12.026.
- Background: PubMed 27069623Boyce 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.
- Background: PubMed 26258903Han 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.
- Background: PubMed 28502637Martin 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.
- BackgroundThe Israeli Ministry of Health Manual 2006.
- Background: PubMed 22177667Marchaim 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.
- Background: PubMed 23622759Sattar SA, Maillard JY. The crucial role of wiping in decontamination of high-touch environmental surfaces: review of current status and directions for the future. Am J Infect Control. 2013 May;41(5 Suppl):S97-104. doi: 10.1016/j.ajic.2012.10.032.
- Background: PubMed 15754723Baker F, Scott P, Kingsley A. Disposable cleansing wipes. Prof Nurse. 2005 Mar;20(7):45-7.
- Background: PubMed 18538699Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available.
- Background: PubMed 35276310Smith H, Watkins J, Otis M, Hebden JN, Wright MO. Health care-associated infections studies project: An American journal of infection control and national healthcare safety network data quality collaboration case study - Chapter 2 Identifying Healthcare-associated Infections (HAI) for NHSN Surveillance case study vignettes. Am J Infect Control. 2022 Jun;50(6):695-698. doi: 10.1016/j.ajic.2022.02.028. Epub 2022 Mar 8.
- Background: PubMed 31913060Zilberman-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dror Marchaim, MD principal investigator
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-use wipes installed at the bedside in people with Hospital Acquired Infection, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device-related HAI rates (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05522725, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.