Health Care Associated InfectionNCT05844683
Effect Of Bath Wıth Chlorexıdıne On Protectıon Of Skın Integrıty And Preventıon Of Hospıtal Infectıon
A study testing 2% chlorhexidine digluconate solution and usual baths in people with Health Care Associated Infection and Skin, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
The study was designed in a randomized controlled experimental design type to determine the effect of a 2% chlorhexidine bath applied in the pediatric intensive care unit on protecting skin integrity and preventing hospital-acquired infection. Read more about this study
- Who is it for?
- Ages 2 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Care Associated Infection, Skin
- What is being tested?
- 2% chlorhexidine digluconate solution and usual baths
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 28 Dec 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 2 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- • Between 2 months -18 years old,
- Receiving treatment in the pediatric intensive care unit for at least three days,
- No nosocomial infection before the first 48-72 hours of hospitalization,
- Not using antibiotics in the first hospitalization,
- Not having any skin problems,
- Evaluated as low or moderate by the Northempton pediatric skin rating scale,
- Children who were accepted to be included in the study by their parents were included in the study.
Who cannot join
- • Positive blood cultures at the first admission to the clinic,
- Having a diagnosis and treatment that suppresses the immune system,
- Followed up with the diagnosis of cancer,
- Receiving steroid therapy for 10 days or more,
- Having arterial catheterization,
- In the postoperative period, the integrity of the skin is impaired, the operation scar,
Show all 9Show fewer
- Having a skin disease known to affect the skin barrier function,
- Those with burn injuries,
- Children with a known history of allergy to chlorhexidine were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The study was designed in a randomized controlled experimental design type to determine the effect of a 2% chlorhexidine bath applied in the pediatric intensive care unit on protecting skin integrity and preventing hospital-acquired infection. Research data were collected from pediatric patients aged 2 months to 18 years old, who were treated in the Pediatric Intensive Care Unit of a tertiary education and research hospital between September 2022 and September 2023. In data collection; "Child Follow-up Form", "Skin Integrity and Nosocomial Infection Follow-up Form", and "Northampton Pediatric Skin Evaluation Scale (CCRS)" were used. The data were evaluated with appropriate statistical methods in SPSS (Statistical Package for Social Sciences) for Windows 24.0 package program.
Read the detailed description
The study is planned to be carried out between September 2022 and September 2023 in the 15-bed pediatric intensive care unit of Sarıyer Hamidiye Etfal Hospital. Sample size was determined by power analysis. Based on the percentage measurement values of the methods to be studied in the literature review, the total sample size was found to be n=68, with an effect size of 0.8 (cohen), a power of 90%, and a margin of error of 0.05, using the G-POWER program. The sample of the study was determined as 68 children, 34 of whom were bathed with 2% Chlorhexidine soap and 34 children who were bathed with water and soap. The randomization of the groups will be determined by drawing lots.
The pediatric intensive care unit works in two shifts, 08-17 and 16-08. During the research, the researcher will be in the clinic during the procedure, bathroom applications will be made by the research nurse in the 08-17 shift and recorded in the data collection form. A blood culture will be taken at the first hospitalization for each child who meets the acceptance and exclusion criteria of the study hospitalized in the pediatric intensive care unit, and their names will be written on closed papers by randomization drawing method and randomly thrown into the lanterns representing the control and intervention groups prepared beforehand. process will be started. Those with negative culture results at their first admission to the clinic will be included in the study.
It is known that healthcare-associated infections occur within 48 to 72 hours of hospitalization. For this reason, for both groups included in the study, necessary blood tests and cultures will be taken at their first admission to the clinic in order to evaluate the effects of the products to be used in the care process on health care-associated infections. During the application, children will be monitored daily by suspecting any systemic inflammatory response syndrome (such as fever, vomiting, diarrhea) in terms of healthcare-associated infections, and in case of any symptoms, their examinations will be repeated and recorded in the data collection form.
For the control and intervention groups, daily bathing will be done during the patient's stay in the clinic, skin evaluation will be made with the Northempton Pediatric Skin Evaluation Scale before the application, and the application process will begin for the pediatric patients whose scale score is between low and medium level and will be evaluated daily after the application. If a change is noted in the Northempton Pediatric Skin Rating Scale skin score during daily evaluations, the evaluations will continue within the intervals specified in the form of the scale, and the study will be terminated for children whose scale score is evaluated in the high-risk group. In addition, the evaluation of skin integrity will be recorded daily on the data collection form immediately after each application (dryness, redness, deterioration of skin integrity/peeling). Immediately after each application and 6 hours after the FCM-2 Skin Oil and Moisture Meter (With this device, the fat and moisture ratios of any part of the body can be determined and the measurements are concluded with high precision. Measuring range; 0%…99.9% RH) device. skin moisture values will be measured from three different regions, namely forearm, lateral upper leg and abdomen (2 cm above the umbilicus) and recorded daily in the data collection form.
Reproductive findings of healthcare-associated infections will be determined by evaluating the results of the samples sent to Sarıyer Hamidiye Etfal Training and Research Hospital laboratory.
In the study, "Northempton Pediatric Skin Evaluation Scale Turkish Version" will be used for risk assessment of skin integrity. The validity and reliability of the Turkish version of the scale was determined by Uysal et al. (2017) made by The scale is used to evaluate the skin of inpatients in pediatric clinics. Scale child's skin; weight, nutritional status, activity, bladder/bowel control, pain status, and skin condition. Each subscale consists of a total of 18 items with certain criteria. The lowest score to be obtained from the items in the scale was determined as zero and the highest score as 12. In the scale, 2 points will be added to the total score for each of the conditions such as radiotherapy, chemotherapy, steroid treatment, diabetes mellitus, staying in surgery for more than 2 hours, having a splint/cast in the body, anemia (hb: less than 8), sensory loss. A low risk of skin complications between 0-4 points in the scale and once-daily evaluation is recommended. A score of 5 to 8 is at moderate risk for skin complications, and twice-daily evaluation is recommended. It is recommended that skin complications may develop at a high risk with a score of 9 and above, and it is recommended to be evaluated every 4-6 hours or according to the situation. The higher the score on the scale, the higher the risk of skin complications in children who underwent the scale application.
The data obtained in the research is SPSS (Statistical Package for Social Analysis using the Sciences) for Windows 24.0 program will be. Number, percentage, mean and standard deviation will be used as descriptive statistical methods in the evaluation of the data. Before the data analysis, normality test will be done to test the suitability to the parametric test methods. In order to test the normal distribution condition, Kolmogorov Smirnov Z test will be applied. Chi-square and Fisher's exact tests will be applied to determine the homogeneity of the groups. In line with the results, the data will be analyzed with the related tests (Independent t-test, ANOVA, Man Whitney U, Kruskal Wallis). The findings will be evaluated at the 95% confidence interval and the significance level of p<0.05.
- Conditions
- Health Care Associated Infection, Skin
- Being tested
- 2% chlorhexidine digluconate solution, usual baths
- Keywords
- skin integrity, health care associated infection
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% chlorhexidine digluconate solutionOther
Also called chlorhexidine baths
Bathing will be performed at least daily using 2% chlorhexidine digluconate solution with surface-active agents on all applicable bathing surfaces, which consists of the entire body surface of the patient except eyes, inner ear, oral mucosa, and areas of loss of skin continuity (such as burnt areas, pressure injuries, etc.)
usual bathsOther
Also called shampoo and water baths
Bathing will be performed at least daily using shampoo and water (performed according to the current practice in each center) on all applicable bathing surfaces, which consists of the entire body surface of the patient except eyes, inner ear, oral mucosa, and areas of loss of skin continuity (such as burnt areas, pressure injuries, etc.)
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine Bath | Experimental | All patients in the randomized to the intervention arm will receive baths using a 2% chlorhexidine digluconate solution Receives: Other: 2% chlorhexidine digluconate solution |
| usual bath | Active comparator | All patients in the randomized to the intervention arm will receive baths using soap and water according to the current practice Receives: Other: usual baths |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin integrity
Northampton Pediatric Skin Assessment Tool was used for skin integrity
Measured: From admission to discharge, up to 3 days
hospital acquired infection
incidence of hospital acquired infection
Measured: From admission to discharge, up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Sep 2022
- Primary completion25 Dec 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care Associated InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zühal çavuşoğlu, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844683
- Sponsor's protocol ID
- 1282
- Status last verified
- Apr 2023
- First submitted
- 23 Jan 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Bath Wıth Chlorexıdıne On Protectıon Of Skın Integrıty And Preventıon Of Hospıtal Infectıon
- ClinicalTrials.gov ID
- NCT05844683
- Acronym / sponsor ID
- 1282
- Conditions
- Health Care Associated Infection, Skin
- Keywords
- skin integrity, health care associated infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 25 Dec 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 6 May 2023 (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.
The study was designed in a randomized controlled experimental design type to determine the effect of a 2% chlorhexidine bath applied in the pediatric intensive care unit on protecting skin integrity and preventing hospital-acquired infection. Research data were collected from pediatric patients aged 2 months to 18 years old, who were treated in the Pediatric Intensive Care Unit of a tertiary education and research hospital between September 2022 and September 2023. In data collection; "Child Follow-up Form", "Skin Integrity and Nosocomial Infection Follow-up Form", and "Northampton Pediatric Skin Evaluation Scale (CCRS)" were used. The data were evaluated with appropriate statistical methods in SPSS (Statistical Package for Social Sciences) for Windows 24.0 package program.
Detailed description
The study is planned to be carried out between September 2022 and September 2023 in the 15-bed pediatric intensive care unit of Sarıyer Hamidiye Etfal Hospital. Sample size was determined by power analysis. Based on the percentage measurement values of the methods to be studied in the literature review, the total sample size was found to be n=68, with an effect size of 0.8 (cohen), a power of 90%, and a margin of error of 0.05, using the G-POWER program. The sample of the study was determined as 68 children, 34 of whom were bathed with 2% Chlorhexidine soap and 34 children who were bathed with water and soap. The randomization of the groups will be determined by drawing lots.
The pediatric intensive care unit works in two shifts, 08-17 and 16-08. During the research, the researcher will be in the clinic during the procedure, bathroom applications will be made by the research nurse in the 08-17 shift and recorded in the data collection form. A blood culture will be taken at the first hospitalization for each child who meets the acceptance and exclusion criteria of the study hospitalized in the pediatric intensive care unit, and their names will be written on closed papers by randomization drawing method and randomly thrown into the lanterns representing the control and intervention groups prepared beforehand. process will be started. Those with negative culture results at their first admission to the clinic will be included in the study.
It is known that healthcare-associated infections occur within 48 to 72 hours of hospitalization. For this reason, for both groups included in the study, necessary blood tests and cultures will be taken at their first admission to the clinic in order to evaluate the effects of the products to be used in the care process on health care-associated infections. During the application, children will be monitored daily by suspecting any systemic inflammatory response syndrome (such as fever, vomiting, diarrhea) in terms of healthcare-associated infections, and in case of any symptoms, their examinations will be repeated and recorded in the data collection form.
For the control and intervention groups, daily bathing will be done during the patient's stay in the clinic, skin evaluation will be made with the Northempton Pediatric Skin Evaluation Scale before the application, and the application process will begin for the pediatric patients whose scale score is between low and medium level and will be evaluated daily after the application. If a change is noted in the Northempton Pediatric Skin Rating Scale skin score during daily evaluations, the evaluations will continue within the intervals specified in the form of the scale, and the study will be terminated for children whose scale score is evaluated in the high-risk group. In addition, the evaluation of skin integrity will be recorded daily on the data collection form immediately after each application (dryness, redness, deterioration of skin integrity/peeling). Immediately after each application and 6 hours after the FCM-2 Skin Oil and Moisture Meter (With this device, the fat and moisture ratios of any part of the body can be determined and the measurements are concluded with high precision. Measuring range; 0%…99.9% RH) device. skin moisture values will be measured from three different regions, namely forearm, lateral upper leg and abdomen (2 cm above the umbilicus) and recorded daily in the data collection form.
Reproductive findings of healthcare-associated infections will be determined by evaluating the results of the samples sent to Sarıyer Hamidiye Etfal Training and Research Hospital laboratory.
In the study, "Northempton Pediatric Skin Evaluation Scale Turkish Version" will be used for risk assessment of skin integrity. The validity and reliability of the Turkish version of the scale was determined by Uysal et al. (2017) made by The scale is used to evaluate the skin of inpatients in pediatric clinics. Scale child's skin; weight, nutritional status, activity, bladder/bowel control, pain status, and skin condition. Each subscale consists of a total of 18 items with certain criteria. The lowest score to be obtained from the items in the scale was determined as zero and the highest score as 12. In the scale, 2 points will be added to the total score for each of the conditions such as radiotherapy, chemotherapy, steroid treatment, diabetes mellitus, staying in surgery for more than 2 hours, having a splint/cast in the body, anemia (hb: less than 8), sensory loss. A low risk of skin complications between 0-4 points in the scale and once-daily evaluation is recommended. A score of 5 to 8 is at moderate risk for skin complications, and twice-daily evaluation is recommended. It is recommended that skin complications may develop at a high risk with a score of 9 and above, and it is recommended to be evaluated every 4-6 hours or according to the situation. The higher the score on the scale, the higher the risk of skin complications in children who underwent the scale application.
The data obtained in the research is SPSS (Statistical Package for Social Analysis using the Sciences) for Windows 24.0 program will be. Number, percentage, mean and standard deviation will be used as descriptive statistical methods in the evaluation of the data. Before the data analysis, normality test will be done to test the suitability to the parametric test methods. In order to test the normal distribution condition, Kolmogorov Smirnov Z test will be applied. Chi-square and Fisher's exact tests will be applied to determine the homogeneity of the groups. In line with the results, the data will be analyzed with the related tests (Independent t-test, ANOVA, Man Whitney U, Kruskal Wallis). The findings will be evaluated at the 95% confidence interval and the significance level of p<0.05.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine Bath | Experimental | Other: 2% chlorhexidine digluconate solutionAll patients in the randomized to the intervention arm will receive baths using a 2% chlorhexidine digluconate solution |
| usual bath | Active comparator | Other: usual bathsAll patients in the randomized to the intervention arm will receive baths using soap and water according to the current practice |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- • Between 2 months -18 years old,
- Receiving treatment in the pediatric intensive care unit for at least three days,
- No nosocomial infection before the first 48-72 hours of hospitalization,
- Not using antibiotics in the first hospitalization,
- Not having any skin problems,
Key exclusion criteria (9 listed)
- • Positive blood cultures at the first admission to the clinic,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2% chlorhexidine digluconate solutionAlso: chlorhexidine bathsBathing will be performed at least daily using 2% chlorhexidine digluconate solution with surface-active agents on all applicable bathing surfaces, which consists of the entire body surface of the patient except eyes, inner ear, oral mucosa, and areas of loss of skin continuity (such as burnt areas, pressure injuries, etc.) | Other | Chlorhexidine Bath |
| usual bathsAlso: shampoo and water bathsBathing will be performed at least daily using shampoo and water (performed according to the current practice in each center) on all applicable bathing surfaces, which consists of the entire body surface of the patient except eyes, inner ear, oral mucosa, and areas of loss of skin continuity (such as burnt areas, pressure injuries, etc.) | Other | usual bath |
Primary outcome
skin integrity
Time frame: From admission to discharge, up to 3 days
Northampton Pediatric Skin Assessment Tool was used for skin integrity
hospital acquired infection
Time frame: From admission to discharge, up to 3 days
incidence of hospital acquired infection
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 6 May 2023.
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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?
A study testing 2% chlorhexidine digluconate solution and usual baths in people with Health Care Associated Infection and Skin, run by Okan 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 7 inclusion and 9 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 6 May 2023. 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?
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?
skin integrity (time frame: From admission to discharge, up to 3 days). The study lists 2 primary outcomes in all. 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 6 May 2023.