Comparison of the Permanent Skin Flora of Children Who Had Bathing With Two Different Products
Comparison of the Permanent Skin Flora of Children Who Had Bathing With Two Different Products: A Randomized Controlled Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Çağrı Özçelik, PhD
- Phone Number: +905327484745
- Email: ccovener@gmail.com
Study Contact Backup
- Name: Berna Turan, BSC
- Phone Number: 00905382609668
- Email: bernaturan1@gmail.com
Study Locations
-
-
Maltepe
-
Istanbul, Maltepe, Turkey, 34854
- Recruiting
- Çağrı Çövener Özçelik
-
Contact:
- Çağrı Çövener Özçelik
- Phone Number: 05327484745
- Email: ccovener@gmail.com
-
Principal Investigator:
- Berna Turan, BSC
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.)
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
EXPERIMENTAL: 2% chlorhexidine gluconate
4% Chlorhexidine gluconate solution and one to one water will be used to create a 2% Chlorhexidine gluconate solution.
|
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.
|
|
ACTIVE_COMPARATOR: soap-free body cleaning solution
It supports and protects the natural barrier function of the skin's natural protective layer.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
permanent skin flora
Time Frame: 3 days
|
Blood Agar Base will be used to evaluate permanent skin flora
|
3 days
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- Human Microbiome Project Consortium. A framework for human microbiome research. Nature. 2012 Jun 13;486(7402):215-21. doi: 10.1038/nature11209.
- 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.
- Grice EA, Segre JA. The skin microbiome. Nat Rev Microbiol. 2011 Apr;9(4):244-53. doi: 10.1038/nrmicro2537. Erratum In: Nat Rev Microbiol. 2011 Aug;9(8):626.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ANTICIPATED)
Primary Completion
Study Completion (ANTICIPATED)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 01/28
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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