Safety IssuesNCT04904666
Safety and Efficacy of Bleach Baths in Non Critical Hospitalized Patients
An observational study of Safety Issues, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- How many people
- 76 participants
- Where
- 1 siteMexico
- Study dates
- 26 Nov 2019to 26 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Non critical hospitalized patients in internal medicine that met inclusion criteria. Subjects should be hospitalized por 1 week.
Who may be able to join
- Non critical hospitalized patients in internal medicine
- 18 years old and older
Who cannot join
- Burn patients
- Pregnant women
- Chloride hypersensitivity
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario José E. Gonzalez
Monterrey, Nuevo León, 64460
About this study
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.
- Conditions
- Safety Issues
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bleach baths with .0125% | Not described | |
| Clorhexidine 2% | Not described | |
| Soap and water | Not described | |
| Bleach baths with .005% | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Bleach baths as determined by the incidence of adverse or serious adverse events
Measured: November 26, 2019 - October 25, 2020
Secondary outcomes (2)
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
Measured: November 26, 2019 - October 25, 2020
Percentage of patients remaining colonized 3, 5 and 7 days after daily baths
Measured: November 26, 2019 - October 25, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start26 Nov 2019
- Primary completion26 Oct 2020
- Study completion26 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Adrian Camacho-Ortiz, Hospital Universitario Dr. Jose E. Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904666
- Sponsor's protocol ID
- IF19-00010
- Status last verified
- May 2021
- First submitted
- 22 Feb 2021
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Bleach Baths in Non Critical Hospitalized Patients
- ClinicalTrials.gov ID
- NCT04904666
- Acronym / sponsor ID
- IF19-00010
- Conditions
- Safety Issues
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 26 Oct 2020 (actual)
- Study completion
- 26 Oct 2020 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bleach baths with .0125% | – | – |
| Clorhexidine 2% | – | – |
| Soap and water | – | – |
| Bleach baths with .005% | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Non critical hospitalized patients in internal medicine that met inclusion criteria. Subjects should be hospitalized por 1 week.
Key inclusion criteria (2 listed)
- Non critical hospitalized patients in internal medicine
- 18 years old and older
Key exclusion criteria (3 listed)
- Burn patients
- Pregnant women
- Chloride hypersensitivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety of Bleach baths as determined by the incidence of adverse or serious adverse events
Time frame: November 26, 2019 - October 25, 2020
2 secondary outcomes
Identification of bacterial colonization from pathogens belonging to the ESKAPE group
Time frame: November 26, 2019 - October 25, 2020
Percentage of patients remaining colonized 3, 5 and 7 days after daily baths
Time frame: November 26, 2019 - October 25, 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Individual participant dataSharing planned: No
Related trials for Safety Issues
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruitingPhase 1
Phase 1 Study to Evaluate RG002C0106 Injection in Healthy Participants
Safety Issues
Enrolling by invitation
Pediatric Trauma Centers RE-AIM at Gun Safety
Firearm Injury, Safety Issues
RecruitingObservational study
Efficacy and Safety of a New Sperm Capacitation Method
Reproductive Issues, Male Infertility
Active, not recruitingPhase 1/2
Role of a CCK Receptor Antagonist Proglumide in Management of Chronic Pancreatitis
Safety Issues, Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety Issues, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Bleach baths as determined by the incidence of adverse or serious adverse events (time frame: November 26, 2019 - October 25, 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.