Safety and Efficacy of Bleach Baths in Non Critical Hospitalized Patients

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.

Study Overview

• Status: Completed
• Conditions: Safety Issues

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• Mexico
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Hospital Universitario José E. Gonzalez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Non critical hospitalized patients in internal medicine that met inclusion criteria. Subjects should be hospitalized por 1 week.

Description

Inclusion Criteria:

• Non critical hospitalized patients in internal medicine
• 18 years old and older

Exclusion Criteria:

• Burn patients
• Pregnant women
• Chloride hypersensitivity

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Bleach baths with .0125%
Clorhexidine 2%
Soap and water
Bleach baths with .005%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety of Bleach baths as determined by the incidence of adverse or serious adverse events	November 26, 2019 - October 25, 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of bacterial colonization from pathogens belonging to the ESKAPE group	Identification of colonization by Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacter species	November 26, 2019 - October 25, 2020
Percentage of patients remaining colonized 3, 5 and 7 days after daily baths		November 26, 2019 - October 25, 2020

Collaborators and Investigators

• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2019
• Primary Completion (Actual): October 26, 2020
• Study Completion (Actual): October 26, 2020

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 24, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: IF19-00010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No