ChlorhexidineNCT05142969
Chlorhexidine Bathing to Prevent Hospital-acquired Infections: the CLEANS Study
A study testing 2% Chlorhexidine bathing in people with Chlorhexidine and Hospital-Acquired Infection, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Hospital-acquired infections (HAI) have been shown to increase length of hospital stay and mortality. Infections acquired during a hospital stay have been shown to be preventable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chlorhexidine, Hospital-Acquired Infection, Surgery
- What is being tested?
- 2% Chlorhexidine bathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 31 Dec 2023
- 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
- adults (≥ 18-years old)
- anticipated SICU stay for 48 hours or more
- APACHE II >15
Who cannot join
- Braden Scale for Predicting Pressure Sore Risk score more than 9 (highest risk)
- pregnancy
- skin irritation
- chlorhexidine allergy
- SICU stay of more than 48 hours prior to screening
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality
Shining Cai
About this study
Official title: Effect of Chlorhexidine Bathing on Prevention of Hospital-Acquired Infections in Patients After Surgery in ICU: A Prospective, Single-Center, Single-Blind, Randomized Controlled Trial
Hospital-acquired infections (HAI) have been shown to increase length of hospital stay and mortality. Infections acquired during a hospital stay have been shown to be preventable. The skin of patients is considered a major reservoir for pathogens associated with hospital-acquired infections, and has been suggested as a potential target for interventions to reduce bacterial burden and subsequent risk of infection. The use of daily Chlorhexidine (CHG) bathing in intensive care patients has been advocated to reduce many of the infections in critically ill patients. However, the effectiveness of CHG bathing to reduce ICU infections has varied considerably among published trials, making the effectiveness of CHG bathing in ICU patients uncertain.
- Being tested
- 2% Chlorhexidine bathing
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% Chlorhexidine bathingOther
Eight chlorhexidine-impregnated cloths are used in sequential order to wipe the body surfaces from neck to toe to avoid exposure of chlorhexidine to the mucous membranes of the eyes, ears and mouth.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Patients were daily bathed with soap and water only. |
| Intervention arm | Experimental | Patients were daily bathed with soap and water and then receive 2% Chlorhexidine bathing (Petel Skin care wipes, Likang LtD, shanghai, China). Receives: Other: 2% Chlorhexidine bathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hospital-acquired infections
Including bloodstream infections (BSI), central line-associated BSI (CLABSI), ventilator-associated pneumonia (VAP) and catheter-associated urinary tract infection (CAUTI).
Measured: throughout study completion, an average of 7 days
Secondary outcomes (1)
Multidrug-resistant bacterial colonization free time
Time that the swab samples collected from axilla and groin were persistently negative for target MDR throughout ICU admission.
Measured: throughout study completion, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Dec 2021
- Primary completion1 Mar 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChlorhexidineStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 247 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142969
- Sponsor's protocol ID
- 2020ZSLC69
- Status last verified
- Nov 2021
- First submitted
- 21 Nov 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chlorhexidine Bathing on Prevention of Hospital-Acquired Infections in Patients After Surgery in ICU: A Prospective, Single-Center, Single-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05142969
- Acronym / sponsor ID
- 2020ZSLC69
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 247 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 3 Dec 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.
Hospital-acquired infections (HAI) have been shown to increase length of hospital stay and mortality. Infections acquired during a hospital stay have been shown to be preventable. The skin of patients is considered a major reservoir for pathogens associated with hospital-acquired infections, and has been suggested as a potential target for interventions to reduce bacterial burden and subsequent risk of infection. The use of daily Chlorhexidine (CHG) bathing in intensive care patients has been advocated to reduce many of the infections in critically ill patients. However, the effectiveness of CHG bathing to reduce ICU infections has varied considerably among published trials, making the effectiveness of CHG bathing in ICU patients uncertain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Patients were daily bathed with soap and water only. |
| Intervention arm | Experimental | Other: 2% Chlorhexidine bathingPatients were daily bathed with soap and water and then receive 2% Chlorhexidine bathing (Petel Skin care wipes, Likang LtD, shanghai, China). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults (≥ 18-years old)
- anticipated SICU stay for 48 hours or more
- APACHE II >15
Key exclusion criteria (5 listed)
- Braden Scale for Predicting Pressure Sore Risk score more than 9 (highest risk)
- pregnancy
- skin irritation
- chlorhexidine allergy
- SICU stay of more than 48 hours prior to screening
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 |
|---|---|---|
| 2% Chlorhexidine bathingEight chlorhexidine-impregnated cloths are used in sequential order to wipe the body surfaces from neck to toe to avoid exposure of chlorhexidine to the mucous membranes of the eyes, ears and mouth. | Other | Intervention arm |
Primary outcome
Incidence of hospital-acquired infections
Time frame: throughout study completion, an average of 7 days
Including bloodstream infections (BSI), central line-associated BSI (CLABSI), ventilator-associated pneumonia (VAP) and catheter-associated urinary tract infection (CAUTI).
1 secondary outcome
Multidrug-resistant bacterial colonization free time
Time frame: throughout study completion, an average of 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% Chlorhexidine bathing in people with Chlorhexidine and Hospital-Acquired Infection, run by Shanghai Zhongshan Hospital 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 3 inclusion and 5 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 29 Dec 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. 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 Shining Cai, PhD (02164041990, cai.shining@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hospital-acquired infections (time frame: throughout study completion, an average of 7 days). 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 29 Dec 2021.