- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07233837
Hydrogen Peroxide and Ultraviolet Light for Disinfecting Surfaces in Intensive Care Units (Hylight)
Hydrogen Peroxide and Ultraviolet Light for Disinfecting Surfaces in Intensive Care Units: A Randomized, Controlled, Cluster, Crossover Clinical Trial
Healthcare-associated infections (HAIs) remain a major problem in intensive care units (ICUs), driven by environmental contamination with multidrug-resistant organisms that persist despite routine manual cleaning. While hydrogen peroxide aerosolization and ultraviolet-C light devices have shown promise in reducing surface contamination, current evidence is inconsistent, mostly derived from single-center studies, and rarely linked to patient-centered outcomes.
The investigators will conduct this cluster-randomized, crossover trial in 12 Brazilian ICUs. Each ICU will sequentially implement three strategies: (1) usual surface disinfection; (2) usual surface disinfection followed by hydrogen peroxide aerosolization at 7.9% concentration, applied through a dedicated device inside a protective tent during terminal cleaning of patient beds; and (3) usual surface disinfection followed by automated ultraviolet-C irradiation, also applied under the same tent to shield adjacent occupied beds.
The primary outcome will be the antimicrobial utilization, measured as daily defined doses (DDD) of antimicrobials at the ICU level per 100 patient-days, with secondary outcomes including HAI incidence rate, environmental contamination with multidrug-resistant organisms, specific HAIs incidence rate (associated-ventilator pneumonia, central-line associated bloodstream infection, and catheter-associated urinary tract infection), and ICU length of stay costs.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Antonio P Nassar Jr, PhD
- Phone Number: 551121519617
- Email: antonio.nassar@einstein.br
Study Contact Backup
- Name: Adriano J Pereira, PhD
- Phone Number: 551121519617
- Email: Adriano.Pereira2@einstein.br
Study Locations
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Recife, Brazil
- Recruiting
- Hospital Pelópidas Silveira
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Contact:
- Livia A de Medeiros
- Phone Number: 55-81-3183-0388
- Email: liviamedeiros@hotmail.com
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Ceará
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Barbalha, Ceará, Brazil
- Recruiting
- Hospital Maternidade Sao Vicente De Paulo
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Contact:
- Meton S Alencar Filho
- Phone Number: 55-85-3532-7100
- Email: meton.filho@icloud.com
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Federal District
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Brasília, Federal District, Brazil
- Recruiting
- Instituto Hospital de Base
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Contact:
- Glecia C Rocha
- Phone Number: 55-61-3550-8900
- Email: gleciacarla@yahoo.com.br
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Goiás
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Aparecida de Goiânia, Goiás, Brazil
- Recruiting
- Hospital Estadual de Aparecida de Goiânia
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Contact:
- Wallef S Rodrigues
- Phone Number: 55-62-3983-1750
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Minas Gerais
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Passos, Minas Gerais, Brazil
- Recruiting
- Santa Casa de Misericordia de Passos
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Contact:
- Priscila F Gonçalves
- Phone Number: 88-35-3529-1300
- Email: ccih.coordenacao@scpassos.org.br
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Paraná
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Maringá, Paraná, Brazil
- Recruiting
- Fundo Municipal de Saúde de Maringá
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Contact:
- Francielle C Pereira
- Phone Number: 55-44-3127-3100
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Pernambuco
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Recife, Pernambuco, Brazil
- Recruiting
- Hospital da Restauração
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Contact:
- Debora M Pinho
- Phone Number: 55-81-3181-5400
- Email: debypinho61@gmail.com
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Piauí
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Teresina, Piauí, Brazil
- Recruiting
- Hospital Universitário da Universidade Federal do Piauí
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Contact:
- Rejane M Prestes
- Phone Number: 55-86-3228-5201
- Email: prestesrejane@gmail.com
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brazil
- Recruiting
- Hospital Universitário Onofre Lopes
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Contact:
- Eliane P da Silva
- Phone Number: 55-84-3342-5000
- Email: eliane.psilva@esberh.gov.br
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Rio Grande do Sul
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Caxias do Sul, Rio Grande do Sul, Brazil
- Recruiting
- Hospital Geral de Caxias do Sul
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Contact:
- Emerson B da Silva
- Phone Number: 55543128700
- Email: boschimd@gmail.com
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Porto Alegre, Rio Grande do Sul, Brazil
- Recruiting
- Hospital de Pronto Socorro de Porto Alegre
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Contact:
- Marcelle R Schettert
- Phone Number: 55-51-3289-7999
- Email: marcelle.schettert@portoalegre.rs.gov.br
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São Paulo
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Itapetininga, São Paulo, Brazil
- Recruiting
- Hospital Dr Leo Orsi Bernardes
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Contact:
- Vivian M Irineu
- Phone Number: 55-15-3275-7800
- Email: virineu@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All patients aged 18 years and older who will be admitted to the participating ICUs
Exclusion Criteria:
- Patients under 18 years
- ICUs that use peroxide hydrogen or ultraviolet light for surface disinfection as part of their protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Surface disinfection with aerosolized hydrogen peroxide
The hygiene team of each participating ICU will spray aerosolized peroxide hydrogen using a specific device when performing terminal cleaning of the ICU bed after the patient's discharge.
As peroxide hydrogen aerosol can be irritating to people nearby, we will use a tent designed to cover the bed and nearby equipment during peroxide hydrogen disinfection, thus preventing aerosols from spreading to other beds and other areas of ICUs where beds are not in closed rooms.
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Spray of aerosolized peroxide hydrogen using a specific device when performing terminal cleaning of the ICU bed after the patient's discharge.
Other Names:
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Experimental: Surface disinfection with irradiation of ultraviolet light
The hygiene team of each participating ICU will use a specific device, requiring no manipulation, for irradiating UV light for the purpose of disinfecting beds and surfaces near beds during terminal cleaning.
To prevent UV irradiation from reaching occupied beds and other areas of the ICU, the same tent described in the "peroxide hydrogen" arm.
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Irradiation of UV light for the purpose of disinfecting beds and surfaces near beds during terminal cleaning.
Other Names:
|
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No Intervention: Usual disinfection
The control group will perform standard cleaning and disinfection of the beds and the environment according to their previous protocols, using the usual products.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Antimicrobial utilization at the ICU level
Time Frame: 3 months
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Antimicrobial utilization, measured as daily defined doses (DDD) of antimicrobials at the ICU level per 100 patient-days
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Contamination of environmental surfaces by multi-resistant microorganisms
Time Frame: 3 months
|
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.
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.
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3 months
|
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Incidence density of ventilator-associated pneumonia
Time Frame: 3 months
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3 months
|
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Incidence density of central line-associated bloodstream infections
Time Frame: 3 months
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3 months
|
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Incidence density of catheter-associated urinary tract infection
Time Frame: 3 months
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3 months
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Intensive care unit length of stay costs
Time Frame: 3 months
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3 months
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Healthcare-associated infections
Time Frame: 3 months
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Incidence rate of device healthcare-associated infections during ICU admission
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3 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Antonio P Nassar Jr, PhD, Hospital Israelita Albert Einstein
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Healthcare-Associated Pneumonia
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Disease Attributes
- Respiratory Tract Infections
- Infections
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia
- Iatrogenic Disease
- Pathological Conditions, Signs and Symptoms
- Urinary Tract Infections
- Pneumonia, Ventilator-Associated
- Cross Infection
- Catheter-Related Infections
- Organic Chemicals
- Environment and Public Health
- Physical Phenomena
- Inorganic Chemicals
- Environment
- Ecological and Environmental Phenomena
- Biological Phenomena
- Weather
- Atmosphere
- Meteorological Concepts
- Anions
- Ions
- Electrolytes
- Oxides
- Oxygen Compounds
- Electromagnetic Phenomena
- Magnetic Phenomena
- Electromagnetic Radiation
- Radiation
- Radiation, Ionizing
- Light
- Optical Phenomena
- Radiation, Nonionizing
- Peroxides
- Reactive Oxygen Species
- Free Radicals
- Sunlight
- Hydrogen Peroxide
- Ultraviolet Rays
Other Study ID Numbers
- CAAE 71265723.0.1001.0071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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