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Skin MicrobiotaNCT04845672

Comparison of the Permanent Skin Flora of Children Who Had Bathing With Two Different Products

A study testing 2% chlorhexidine gluconate and soap-free body cleaning solution in people with Skin Microbiota, run by Marmara University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study was carried out as a randomized controlled experimental study to compare the effect of wiping bath with 2% daily chlorhexidine gluconate and soap-free body wash on the permanent skin flora of children hospitalized in the PICU. Read more about this study

Who is it for?
Ages 1 month to 18 years
Conditions the study is for
Skin Microbiota
What is being tested?
2% chlorhexidine gluconate and soap-free body cleaning solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Feb 2021to 15 Feb 2022
Phase
Interventional
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 1 month to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Being in the first 24 hours of admission to the PICU
  • Internal reasons for hospitalization with children
  • No co-morbid disease
  • Hospitalization in PICU during data collection procedure

Who cannot join

  • Hospitalization just before the study
  • The children who is not available for wiping bath
  • Hospitalized children after surgical procedures
  • Antibotic use during the study
  • Being chlorhexidine gluconate allergy history
  • Impaired skin integrity (burns, skin disease etc.)
Show all 10Show fewer
  • Use of antibiotics, probiotics or steroid-containing immune system suppressing agents at last two months
  • Radiotherapy or the chemotherapy patients
  • Severe septic shock
  • The children with tracheostomy, PEG, permanent dialysis catheter etc.

Trial locations and contacts

1 site in 1 country.

Çağrı Özçelik, PhD contact

+905327484745

ccovener@gmail.com

Berna Turan, BSC contact

00905382609668

bernaturan1@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Çağrı Çövener Özçelik

    Istanbul, Maltepe, 34854

    Çağrı Çövener Özçelik, 05327484745, ccovener@gmail.com

    Berna Turan, BSC

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Permanent Skin Flora of Children Who Had Bathing With Two Different Products: A Randomized Controlled Study

This study was carried out as a randomized controlled experimental study to compare the effect of wiping bath with 2% daily chlorhexidine gluconate and soap-free body wash on the permanent skin flora of children hospitalized in the PICU.

Read the detailed description

Microbiota to the ecosystem formed by symbiotic and pathogenic microorganisms (bacteria, fungi, viruses, archaea, etc.) living in and on the surface of the human body; All of the genes encoding them have been called the microbiome (Whitman et al., 1998). The relationship between microbiota and many diseases that will have important consequences in human life has been proven. Infection and infectious diseases increase the risk of developing complications in critically ill patients, sometimes followed by death. Microbiota in healthy individuals contains many different microorganisms. The microbiota that begins to form immediately after birth varies according to nutrition, genetics, age and geographic region and climate. Human microbiota may change after applications such as infections, use of antibiotics, various chemicals (antiseptic solutions, soaps, shampoos, etc.). This study was planned to compare the effect of wiping bath with 2% daily chlorhexidine gluconate and soap-free body washing solution on the skin microbiota of the patients hospitalized in the PICU. This research will be done as a randomized controlled experimental. The research population consists of 30 pediatric patients hospitalized in the Pediatric Intensive Care Unit of the Health Sciences University Umraniye Training and Research Hospital in 2021, who were wiped with 2% chlorhexidine gluconate, and 30 who were wiped with a soap-free body wash solution. Power analysis was erformed using the G * Power (v3.1.7) program to determine the number of samples. The strength of the study is expressed as 1-β (= type II error probability) and generally the studies should have 80% power. According to Cohen's effect size coefficients; Assuming that the evaluations to be made between two independent groups will have a large effect size (d = 0.8), it was decided to recruit 30 people, considering that there should be at least 26 people in each group at the level of α = 0.05 and there might be losses in the working process. The research sample was randomly divided into branches; group I will consist of 30 patients and group II will consist of 30 patients. Children in Group I will be applied soap-free body washing solution and children in Group II will be applied a wipe bath with 2% chlorhexidinegluconate, which is the routine application of the unit. In both groups, swab samples will be taken from the right armpit and right groin before and after the wipe bath (6th hour). '' Child Identification Form'' and ''Wipe Bathroom Application Chart'' will be used to collect data. The Child Diagnostic Form consists of questions containing information about the child (age, gender, reason for hospitalization, date, etc.). It is planned to record information on the wiping bath application schedule, the skin reactions that may occur in the patient during the wiping bath and the effect on the skin flora in the swab samples taken before and after the children's bath applications. Data collection tools will be filled in by the researcher through observation. During the data collection process, it was decided by the researcher to take swab samples before each wipe bath application and after the wipe bath application (6th hour) in order to check whether there was growth in the skin flora of the child's armpit and groin areas. Before the research, the parents of the participants will be informed about the research and verbal / written consent will be obtained from the parents declaring their acceptance to participate in the study. Collected data will be evaluated using the SPSS Statistics 22 package program. At the end of the study, it is thought that it will guide the improvement of patient care quality.

Conditions
Skin Microbiota
Being tested
2% chlorhexidine gluconate, soap-free body cleaning solution
Keywords
Microbiota, Skin Flora, Wipe Bath, Chlorhexidine Gluconate, Soap-Free Body Wash Solution

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2% chlorhexidine gluconateOther

    Children in 2% chlorhexidine gluconate group , which is the routine practice of the hospital, and a wiping bath in accordance with the bath protocol specified. The bath procedure will take 10-15 minutes. Before wiping bath swab sample will provide from armpit and groin with circular manner and 6 hours later swap sample will be provided from the same areas again. The swab sample taken will be planted on blood agar medium and kept at + 4-8 ℃ for an average of 18-24 hours. After it is planted on blood agar medium, it will be kept at + 4-8 ℃ for an average of 18-24 hours . A total of 12 swab samples will be taken for 3 days from each child and from the same areas, body flora will be evaluated.

  • soap-free body cleaning solutionOther

    Children in a wiping bath with soap-free body washing solution group, and a wiping bath in accordance with the bath protocol specified. The bath procedure will take 10-15 minutes. Before wiping bath swab sample will provide from armpit and groin with circular manner and 6 hours later swap sample will be provided from the same areas again. The swab sample taken will be planted on blood agar medium and kept at + 4-8 ℃ for an average of 18-24 hours. After it is planted on blood agar medium, it will be kept at + 4-8 ℃ for an average of 18-24 hours . A total of 12 swab samples will be taken for 3 days from each child and from the same areas, body flora will be evaluated.

Study groups in NCT04845672
Study groupRoleWhat they receive
2% chlorhexidine gluconateExperimental4% Chlorhexidine gluconate solution and one to one water will be used to create a 2% Chlorhexidine gluconate solution.
Receives: Other: 2% chlorhexidine gluconate
soap-free body cleaning solutionActive comparatorIt supports and protects the natural barrier function of the skin's natural protective layer.
Receives: Other: soap-free body cleaning solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. permanent skin flora

    Blood Agar Base will be used to evaluate permanent skin flora

    Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2021
  2. Study start15 Feb 2021
  3. Primary completion15 Feb 2022 (estimated)
  4. Study completion15 Feb 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04845672
Sponsor's protocol ID
01/28
Status last verified
Apr 2021
First submitted
11 Apr 2021
Last updated
19 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chow J, Lee SM, Shen Y, Khosravi A, Mazmanian SK. Host-bacterial symbiosis in health and disease. Adv Immunol. 2010;107:243-74. doi: 10.1016/B978-0-12-381300-8.00008-3.

    PubMed 21034976
  • Clemente JC, Ursell LK, Parfrey LW, Knight R. The impact of the gut microbiota on human health: an integrative view. Cell. 2012 Mar 16;148(6):1258-70. doi: 10.1016/j.cell.2012.01.035.

    PubMed 22424233
  • Costello EK, Lauber CL, Hamady M, Fierer N, Gordon JI, Knight R. Bacterial community variation in human body habitats across space and time. Science. 2009 Dec 18;326(5960):1694-7. doi: 10.1126/science.1177486. Epub 2009 Nov 5.

    PubMed 19892944
  • Elias PM. Stratum corneum defensive functions: an integrated view. J Invest Dermatol. 2005 Aug;125(2):183-200. doi: 10.1111/j.0022-202X.2005.23668.x.

    PubMed 16098026
  • Human Microbiome Project Consortium. A framework for human microbiome research. Nature. 2012 Jun 13;486(7402):215-21. doi: 10.1038/nature11209.

    PubMed 22699610
  • Karki S, Cheng AC. Impact of non-rinse skin cleansing with chlorhexidine gluconate on prevention of healthcare-associated infections and colonization with multi-resistant organisms: a systematic review. J Hosp Infect. 2012 Oct;82(2):71-84. doi: 10.1016/j.jhin.2012.07.005. Epub 2012 Aug 11.

    PubMed 22889522
  • Grice EA, Segre JA. The skin microbiome. Nat Rev Microbiol. 2011 Apr;9(4):244-53. doi: 10.1038/nrmicro2537.

    PubMed 21407241
  • Kong HH, Segre JA. Skin microbiome: looking back to move forward. J Invest Dermatol. 2012 Mar;132(3 Pt 2):933-9. doi: 10.1038/jid.2011.417. Epub 2011 Dec 22.

    PubMed 22189793
  • Whitman WB, Coleman DC, Wiebe WJ. Prokaryotes: the unseen majority. Proc Natl Acad Sci U S A. 1998 Jun 9;95(12):6578-83. doi: 10.1073/pnas.95.12.6578.

    PubMed 9618454

Questions about this trial

What is this clinical trial studying?

A study testing 2% chlorhexidine gluconate and soap-free body cleaning solution in people with Skin Microbiota, run by Marmara University at 1 site in Turkey (Türkiye).

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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 19 Apr 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 Turkey (Türkiye). 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Çağrı Özçelik, PhD (+905327484745, ccovener@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

permanent skin flora (time frame: 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04845672, which also lists 9 linked publications.

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 19 Apr 2021.

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