Safety and Efficacy of Bleach Baths in Non Critical Hospitalized Patients

Safety Issues Clinical Trial

Official title:

Safety and Efficacy of Bleach Baths in Non Critical Hospitalized Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04904666
• Other study ID #: IF19-00010
• Status: Completed
• Start date: November 26, 2019
• Est. completion date: October 26, 2020

Study information

• Verified date: May 2021
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: October 26, 2020
• Est. primary completion date: October 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Burn patients
• Pregnant women
• Chloride hypersensitivity

Related Conditions & MeSH terms

• Safety Issues

Locations

Country	Name	City	State
Mexico	Hospital Universitario José E. Gonzalez	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Bleach baths as determined by the incidence of adverse or serious adverse events		November 26, 2019 - October 25, 2020
Secondary	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
Secondary	Percentage of patients remaining colonized 3, 5 and 7 days after daily baths		November 26, 2019 - October 25, 2020