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

NCT04845672 | Unknown

• 1 other identifier: 01/28
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Microbiota

Keywords

Microbiota; Skin Flora; Wipe Bath; Chlorhexidine Gluconate; Soap-Free Body Wash Solution

Outcome Measures

Primary Outcomes (1)

• permanent skin flora

  Blood Agar Base will be used to evaluate permanent skin flora

  3 days

Study Arms (2)

2% chlorhexidine gluconate

EXPERIMENTAL

4% Chlorhexidine gluconate solution and one to one water will be used to create a 2% Chlorhexidine gluconate solution.

Other: 2% chlorhexidine gluconate

soap-free body cleaning solution

ACTIVE COMPARATOR

It supports and protects the natural barrier function of the skin's natural protective layer.

Other: soap-free body cleaning solution

Interventions

2% chlorhexidine gluconate OTHER

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.

2% chlorhexidine gluconate

soap-free body cleaning solution OTHER

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.

soap-free body cleaning solution

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Çağrı Çövener Özçelik

Istanbul, Maltepe, 34854, Turkey (Türkiye)

RECRUITING

Related Publications (9)

• 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.

  PMID: 21034976 BACKGROUND

• 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.

  PMID: 22424233 BACKGROUND

• 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.

  PMID: 19892944 BACKGROUND

• 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.

  PMID: 16098026 BACKGROUND

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

  PMID: 22699610 BACKGROUND

• 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.

  PMID: 22889522 RESULT

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

  PMID: 21407241 RESULT

• 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.

  PMID: 22189793 RESULT

• 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.

  PMID: 9618454 RESULT

MeSH Terms

Interventions

chlorhexidine gluconate

Central Study Contacts

Çağrı Özçelik, PhD

CONTACT

+905327484745; ccovener@gmail.com

Berna Turan, BSC

CONTACT

00905382609668; bernaturan1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 15, 2021
• Study Start: February 15, 2021
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)