NCT05797103

Brief Summary

The purpose of this study is to test whether spraying the hand of patients by use of the novel electrolyzed water spray will decrease the number of bacteria E-coli and the virus titer of an attenuated human flu virus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2023

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2023

Completed
Last Updated

August 1, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

February 27, 2023

Last Update Submit

July 29, 2023

Conditions

Keywords

Electrolyzed water deviceHydroxyl radicalTap waterSprayE-coliHuman flu virus

Outcome Measures

Primary Outcomes (1)

  • Flush and eradicate the number of bacteria E-coli on human hands.

    Calculate the total number of bacterial colonies formed, expressed as CFU, and the total number of bacterial colonies (CFU) is the total number of colonies formed on the surface of a solid medium in 1 ml of a water sample. Viral titer (TCID50) indicates the minimum number of bacteria or amount of toxin required to infect half of an animal of a certain body weight or age by a specified route of infection within a specified time.

    10 seconds

Study Arms (2)

electrolyzed water spray group

EXPERIMENTAL

Participants with bacteria E-coli and an attenuated human flu virus on their hands will receive one treatment with the novel electrolyzed water and complete the questionnaire.

Device: A novel electrolyzed water spray reduces numbers of bacteria E-coli and an attenuated human flu virus on human hands

untreated tap water group

EXPERIMENTAL

Participants with bacteria E-coli and an attenuated human flu virus on their hands will receive one treatment with the untreated tap water and complete the questionnaire.

Device: A novel electrolyzed water spray reduces numbers of bacteria E-coli and an attenuated human flu virus on human hands

Interventions

Electrolyzed water spray group will use the novel electrolyzed water spray to flush the hands that daub E. coli and attenuated human influenza virus H1N1 for 6 seconds per hand, and then use 4 seconds to collect a sample of the water flowing from the sprayed hand and apply it to the plate. Untreated tap water group will use the untreated tap water spray to flush the hands that daub E. coli and attenuated human influenza virus H1N1 for 6 seconds per hand, and then use 4 seconds to collect a sample of the water flowing from the sprayed hand and apply it to the plate.

electrolyzed water spray groupuntreated tap water group

Eligibility Criteria

Age24 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-60 years.
  • Male or female of any race and ethnicity.
  • Subject agrees to comply with study requirements.

You may not qualify if:

  • Severely unhealthy participants.
  • years or older.
  • Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
  • Dermatologic disease such as psoriasis or atopic dermatitis which may have inherently abnormal antimicrobial peptide levels.
  • Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier.
  • Immunocompromised subjects, or with a history of active or malignant disease as determined by the participant's medical history.
  • Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol.
  • Subjects with significant concurrent medical condition(s) at screening that in the view of the investigator prohibits participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huinuode Biotechnology Co., Ltd.

Qingdao, China

Location

MeSH Terms

Conditions

Escherichia coli Infections

Condition Hierarchy (Ancestors)

Enterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
This is an open label, two arm clinical study
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2023

First Posted

April 4, 2023

Study Start

January 29, 2023

Primary Completion

July 2, 2023

Study Completion

July 27, 2023

Last Updated

August 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations