Infection, HospitalORG-CLEANNCT05673226
Organosilane for Surface Cleaning in Intensive Care Units
A study testing Surface disinfection with Organosilane in people with Infection, Hospital, run by Hospital Israelita Albert Einstein at 14 sites in Brazil.
Trial summary
The purpose of this study is to evaluate if surface disinfection with organosilane associated with traditional cleaning reduces the incidence of healthcare-associated infections (HAIs) in intensive care units when compared with traditional cleaning alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Hospital
- What is being tested?
- Surface disinfection with Organosilane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,301 participants
- Where
- 14 sitesBrazil
- Study dates
- 6 Nov 2023to 30 Jan 2025
- 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
- All patients aged 18 years and older who will be admitted to the participating ICUs
Who cannot join
- Patients under 18 years
- ICUs that may use any organosilane formulation for surface disinfection
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Brazil14 sites
Hospital Jean Bittar
Belém
Santa Casa de Misericórdia
Belo Horizonte
Hospital de Base do Distrito Federal
Brasília
Hospital Universitário de Brasília
Brasília
Hospital Otoclínica
Fortaleza
Hospital Geral de Goiânia
Goiânia
Hospital do Tricentenário
Olinda
Hospital Escola Universidade Federal de Pelotas
Pelotas
Hospital Ernesto Dornelles
Porto Alegre
Hospital Ana Nery
Salvador
Hospital Santa Cruz
Santa Cruz do Sul
Hospital Presidente Vargas
São Luís
A.C. Camargo Cancer Center
São Paulo
Hospital do Coração
São Paulo
About this study
Official title: Organosilane for Surface Cleaning in Intensive Care Units: A Cluster Randomized, Controlled, Crossover, Clinical Trial
The purpose of this study is to evaluate if surface disinfection with organosilane associated with traditional cleaning reduces the incidence of healthcare-associated infections (HAIs) in intensive care units when compared with traditional cleaning alone.
- Conditions
- Infection, Hospital
- Being tested
- Surface disinfection with Organosilane
- Keywords
- Infection Control, Infections, Intensive Care Units, Pneumonia, Ventilator Associated, Catheter-Related Infections, Urinary Tract Infections, Organosilanes, Costs and Cost Analyses
- Medical subject headings
- Cross Infection, Infections, Pneumonia, Ventilator-Associated, Catheter-Related Infections, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface disinfection with OrganosilaneOther
Organosilane will be sprayed on the surfaces, using an atomizer. When the environment has been completely covered (i.e., when all surfaces and equipment have a slightly damp film), we will proceed with the second phase of the disinfection of all heavily touched surfaces. surfaces of the bed, with a microfiber cloth with organosilane.
| Study group | Role | What they receive |
|---|---|---|
| Surface disinfection with organosilane | Experimental | Organosilane will be sprayed on the surfaces, using an atomizer. When the environment has been completely covered (i.e., when all surfaces and equipment have a slightly damp film), we will proceed with the second phase of the disinfection of all heavily touched surfaces. surfaces of the bed, with a microfiber cloth with organosilane. Receives: Other: Surface disinfection with Organosilane |
| Usual surface disinfection | No intervention | The control group will perform standard cleaning and disinfection of the beds and the environment according to their previous protocols, using the usual products. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of healthcare associated infections
Measured: 6 months
Secondary outcomes (5)
Contamination of environmental surfaces by multi-resistant microorganisms
We will collect environmental samples from 4 surfaces highly touched by the patient, health team and family (bed rails, monitor and infusion pump buttons, meal table or procedure table, and IV drip stand) before and after the intervention. (end of the 6 months). For analysis of the environmental samples, characterization of the density and microbiological profile of biofilms on the different surfaces of the ICU beds will be performed using large-scale DNA sequencing techniques associated with bioinformatics analysis.
Measured: 6 months
Incidence of ventilator-associated pneumonia
Measured: 6 months
Incidence of central line-associated blood stream infections
Measured: 6 months
Incidence of catheter-associated urinary tract infection
Measured: 6 months
Intensive care unit length of stay costs
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start6 Nov 2023
- Primary completion13 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, HospitalStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, controlled, cluster, crossover, trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10,301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sirio-Libanes, Hospital Moinhos de Vento, Hospital Alemão Oswaldo Cruz, Hospital do Coracao, Beneficência Portuguesa de São Paulo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673226
- Sponsor's protocol ID
- 52639521.1.1001.0071
- Acronym
- ORG-CLEAN
- Status last verified
- Nov 2023
- First submitted
- 7 Dec 2022
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organosilane for Surface Cleaning in Intensive Care Units: A Cluster Randomized, Controlled, Crossover, Clinical Trial
- ClinicalTrials.gov ID
- NCT05673226
- Acronym / sponsor ID
- ORG-CLEAN / 52639521.1.1001.0071
- Conditions
- Infection, Hospital
- Keywords
- Infection Control, Infections, Intensive Care Units, Pneumonia, Ventilator Associated, Catheter-Related Infections, Urinary Tract Infections, Organosilanes, Costs and Cost Analyses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,301 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Hospital Sirio-Libanes, Hospital Moinhos de Vento, Hospital Alemão Oswaldo Cruz, Hospital do Coracao, Beneficência Portuguesa de São Paulo
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 6 Jan 2023 (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 purpose of this study is to evaluate if surface disinfection with organosilane associated with traditional cleaning reduces the incidence of healthcare-associated infections (HAIs) in intensive care units when compared with traditional cleaning alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled, cluster, crossover, trial
| Arm | Type | Receives |
|---|---|---|
| Surface disinfection with organosilane | Experimental | Other: Surface disinfection with OrganosilaneOrganosilane will be sprayed on the surfaces, using an atomizer. When the environment has been completely covered (i.e., when all surfaces and equipment have a slightly damp film), we will proceed with the second phase of the disinfection of all heavily touched surfaces. surfaces of the bed, with a microfiber cloth with organosilane. |
| Usual surface disinfection | No intervention | –The control group will perform standard cleaning and disinfection of the beds and the environment according to their previous protocols, using the usual products. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients aged 18 years and older who will be admitted to the participating ICUs
Key exclusion criteria (2 listed)
- Patients under 18 years
- ICUs that may use any organosilane formulation for surface disinfection
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 |
|---|---|---|
| Surface disinfection with OrganosilaneOrganosilane will be sprayed on the surfaces, using an atomizer. When the environment has been completely covered (i.e., when all surfaces and equipment have a slightly damp film), we will proceed with the second phase of the disinfection of all heavily touched surfaces. surfaces of the bed, with a microfiber cloth with organosilane. | Other | Surface disinfection with organosilane |
Primary outcome
Incidence of healthcare associated infections
Time frame: 6 months
5 secondary outcomes
Contamination of environmental surfaces by multi-resistant microorganisms
Time frame: 6 months
Incidence of ventilator-associated pneumonia
Time frame: 6 months
Incidence of central line-associated blood stream infections
Time frame: 6 months
Incidence of catheter-associated urinary tract infection
Time frame: 6 months
Intensive care unit length of stay costs
Time frame: 6 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 22 Sep 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surface disinfection with Organosilane in people with Infection, Hospital, run by Hospital Israelita Albert Einstein at 14 sites in Brazil.
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 2 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 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Brazil. 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?
Incidence of healthcare associated infections (time frame: 6 months). 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 22 Sep 2025.