Effect Of Bath Wıth Chlorexıdıne On Protectıon Of Skın Integrıty And Preventıon Of Hospıtal Infectıon

NCT05844683 | Completed

• 1 other identifier: 1282
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Health Care Associated Infection; Skin

Keywords

skin integrity; health care associated infection

Outcome Measures

Primary Outcomes (2)

• skin integrity

  Northampton Pediatric Skin Assessment Tool was used for skin integrity

  From admission to discharge, up to 3 days

• hospital acquired infection

  incidence of hospital acquired infection

  From admission to discharge, up to 3 days

Study Arms (2)

Chlorhexidine Bath

EXPERIMENTAL

All patients in the randomized to the intervention arm will receive baths using a 2% chlorhexidine digluconate solution

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

Other: usual baths

Interventions

2% chlorhexidine digluconate solution OTHER

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.)

Also known as: chlorhexidine baths

Chlorhexidine Bath

usual baths OTHER

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.)

Also known as: shampoo and water baths

usual bath

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- • 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.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Okan University: lead

Study Sites (1)

Okan Üniversitesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: May 6, 2023
• Study Start: September 1, 2022
• Primary Completion: December 25, 2022
• Study Completion: December 28, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-04

Locations

TU (1)