Hospital InfectionNCT04920240
Application of Standardized Cleaning and Disinfection Mode of HFT Surface in Hospital Infection Prevention and Control
A study testing cleaning and disinfection mode for surfaces with high frequency contact and Routine procedure in people with Hospital Infection, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The scientific, feasible and effective mode of standardized cleaning and disinfection of ICU high-frequency contact surfaces is discussed and verified. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hospital Infection
- What is being tested?
- cleaning and disinfection mode for surfaces with high frequency contact and Routine procedure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 432 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- High-frequency contact with the surface of an object by ICU patients and their surroundings; informed consent.
Who cannot join
- Admission < 24 hours; < 18 years old; hospital infection prior to admission to the ICU.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
SAHZhejiangU
Hangzhou, Zhejiang, 310000
Fei Zeng, Bachelor, 13757119536, zengfei@zju.edu.cn
About this study
Official title: Application of Multi-center Unified High-frequency Contact Surface Standardized Cleaning and Disinfection Mode in Hospital Infection Prevention and Control in ICU
The scientific, feasible and effective mode of standardized cleaning and disinfection of ICU high-frequency contact surfaces is discussed and verified.
Read the detailed description
This study is a multi-center unified interventional study, using the front and rear control method, it is proposed to improve the ICU traditional cleaning and disinfection method on the basis of the ICU high-frequency contact surface status survey, explore the best frequency and disinfection method of ICU high-frequency contact surface cleaning and disinfection, establish a multi-center unified ICU high-frequency contact surface standardized cleaning and disinfection mode, in order to achieve the ideal cleaning and disinfection effect, effective prevention and control of ICU hospital infection occurrence and transmission.
- Conditions
- Hospital Infection
- Being tested
- cleaning and disinfection mode for surfaces with high frequency contact, Routine procedure
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cleaning and disinfection mode for surfaces with high frequency contactBehavioural
According to the results of the survey on the status of high frequency contact surface, the corresponding frequency and method of cleaning and disinfection are determined. Set up a multidisciplinary quality control team.
Routine procedureBehavioural
clean the high frequency contact surface like other surfaces
| Study group | Role | What they receive |
|---|---|---|
| routine group | Placebo comparator | In accordance with the "intensive care unit hospital infection prevention and control norms" requirements Receives: Behavioral: Routine procedure |
| Experimental group | Experimental | Implement a multi-center unified ICU high-frequency contact surface standardized cleaning and disinfection mode Receives: Behavioral: cleaning and disinfection mode for surfaces with high frequency contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hospital infections
the difference of Incidence of hospital infections
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start1 Jan 2020
- Primary completion30 Aug 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital InfectionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Factorial
- Model description
- Multi-center unification, before-after study,
- Masking
- None (open label)
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Jiaxing University, Changxing People's Hospital, Yuhang Hospital
- Responsible party
- Sponsor
- Investigators
- Jiangshuyuan Liang, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920240
- Sponsor's protocol ID
- 2020-203
- Status last verified
- May 2021
- First submitted
- 1 Jun 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Multi-center Unified High-frequency Contact Surface Standardized Cleaning and Disinfection Mode in Hospital Infection Prevention and Control in ICU
- ClinicalTrials.gov ID
- NCT04920240
- Acronym / sponsor ID
- 2020-203
- Conditions
- Hospital Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Jiaxing University, Changxing People's Hospital, Yuhang Hospital
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Jun 2021 (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.
The scientific, feasible and effective mode of standardized cleaning and disinfection of ICU high-frequency contact surfaces is discussed and verified.
Detailed description
This study is a multi-center unified interventional study, using the front and rear control method, it is proposed to improve the ICU traditional cleaning and disinfection method on the basis of the ICU high-frequency contact surface status survey, explore the best frequency and disinfection method of ICU high-frequency contact surface cleaning and disinfection, establish a multi-center unified ICU high-frequency contact surface standardized cleaning and disinfection mode, in order to achieve the ideal cleaning and disinfection effect, effective prevention and control of ICU hospital infection occurrence and transmission.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-center unification, before-after study,
| Arm | Type | Receives |
|---|---|---|
| routine group | Placebo comparator | Behavioral: Routine procedureIn accordance with the "intensive care unit hospital infection prevention and control norms" requirements |
| Experimental group | Experimental | Behavioral: cleaning and disinfection mode for surfaces with high frequency contactImplement a multi-center unified ICU high-frequency contact surface standardized cleaning and disinfection mode |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- High-frequency contact with the surface of an object by ICU patients and their surroundings; informed consent.
Key exclusion criteria (1 listed)
- Admission < 24 hours; < 18 years old; hospital infection prior to admission to the ICU.
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 |
|---|---|---|
| cleaning and disinfection mode for surfaces with high frequency contactAccording to the results of the survey on the status of high frequency contact surface, the corresponding frequency and method of cleaning and disinfection are determined. Set up a multidisciplinary quality control team. | Behavioural | Experimental group |
| Routine procedureclean the high frequency contact surface like other surfaces | Behavioural | routine group |
Primary outcome
Incidence of hospital infections
Time frame: 1 year
the difference of Incidence of hospital infections
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- 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.
Jiangshuyuan Liang study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cleaning and disinfection mode for surfaces with high frequency contact and Routine procedure in people with Hospital Infection, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 15 Jul 2021. 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiangshuyuan Liang (13868058705, 2517140@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hospital infections (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2021.