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

NCT ID: NCT04845672

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2022-02-15

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

2% chlorhexidine gluconate

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

Group Type: EXPERIMENTAL

2% chlorhexidine gluconate

Intervention Type: 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.

soap-free body cleaning solution

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

Group Type: ACTIVE_COMPARATOR

soap-free body cleaning solution

Intervention Type: 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.

Interventions

2% chlorhexidine gluconate

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.

Intervention Type: OTHER

soap-free body cleaning solution

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

cagri covener ozcelik

Assoc.Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Çağrı Çövener Özçelik

Istanbul, Maltepe, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Çağrı Özçelik, PhD

Role: CONTACT

ccovener@gmail.com

+905327484745

Berna Turan, BSC

Role: CONTACT

bernaturan1@gmail.com

00905382609668

Facility Contacts

Çağrı Çövener Özçelik

Role: primary

ccovener@gmail.com

05327484745

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Other Identifiers

01/28

Identifier Type: -

Identifier Source: org_study_id