Safety and Efficacy of Bleach Baths in Non Critical Hospi... | NCT04904666

Studies
Safety and Efficacy of Bleach Baths in Non Critical Hospitalized Patients

NCT04904666

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Status

Completed

Last Update Posted

May 27, 2021Actual

Enrollment

76Actual

Phase

Not provided

Conditions

Safety Issues

Interventions

Not provided

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 26, 2019Actual

Primary Completion Date

Oct 26, 2020Actual

Completion Date

Oct 26, 2020Actual

First Submitted Date

Feb 22, 2021

First Submission Date that Met QC Criteria

May 24, 2021

First Posted Date

May 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2021

Last Update Posted Date

May 27, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Adrian Camacho-Ortiz, Head of Infectious Diseases Department, Hospital Universitario Dr. Jose E. GonzalezPrincipal Investigator

Lead Sponsor

Hospital Universitario Dr. Jose E. GonzalezOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Burn patients
Pregnant women
Chloride hypersensitivity

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario José E. Gonzalez		Monterrey	Nuevo León	64460	Mexico

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Label	Type	Description	Intervention Names
Bleach baths with .0125%
Clorhexidine 2%
Soap and water
Bleach baths with .005%