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Safety and Efficacy of Bleach Baths in Non Critical Hospitalized Patients

Sponsor
Hospital Universitario Dr. Jose E. Gonzalez (Other)
Overall Status
Completed
CT.gov ID
NCT04904666
Collaborator
(none)
76
Enrollment
1
Location
11
Actual Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Non critical hospitalized patients were bathed daily with 4 substances: bleach at .005%, bleach at .0125%, clorhexidine 2% and soap and water.

76 patients were enrolled and divided 19 subjects per group. Each patient was cultured with swab technique in palm, antecubital fold and armpit at day 0, day 3 and day 7 of enrollment.

Bacterial cultures were incubated and compared if decolonization occurred. Adverse events were evaluated in all patients.

Only 1 patient had and adverse event and was dry skin. Before patient was enrolled, he had dry skin because of his baseline disease. Moisturizing lotion was applied and patient continue in the study.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    76 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Safety and Efficacy of Bleach Baths in Non Critical Hospitalized Patients
    Actual Study Start Date :
    Nov 26, 2019
    Actual Primary Completion Date :
    Oct 26, 2020
    Actual Study Completion Date :
    Oct 26, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Bleach baths with .0125%
    Clorhexidine 2%
    Soap and water
    Bleach baths with .005%

    Outcome Measures

    Primary Outcome Measures

    1. Safety of Bleach baths as determined by the incidence of adverse or serious adverse events [November 26, 2019 - October 25, 2020]

    Secondary Outcome Measures

    1. Identification of bacterial colonization from pathogens belonging to the ESKAPE group [November 26, 2019 - October 25, 2020]

      Identification of colonization by Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacter species

    2. Percentage of patients remaining colonized 3, 5 and 7 days after daily baths [November 26, 2019 - October 25, 2020]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Non critical hospitalized patients in internal medicine

    • 18 years old and older

    Exclusion Criteria:

    • Burn patients

    • Pregnant women

    • Chloride hypersensitivity

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario José E. Gonzalez Monterrey Nuevo Leon Mexico 64460

    Sponsors and Collaborators

    • Hospital Universitario Dr. Jose E. Gonzalez

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Adrian Camacho-Ortiz, Head of Infectious Diseases Department, Hospital Universitario Dr. Jose E. Gonzalez
    ClinicalTrials.gov Identifier:
    NCT04904666
    Other Study ID Numbers:
    • IF19-00010
    First Posted:
    May 27, 2021
    Last Update Posted:
    May 27, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 27, 2021