Clinical trial NCT06192095: Applying Liquid Skin Barrier Film to Prevent Skin Complications Around Indwelling Vascular Catheters in Pediatric Patients: a Randomized Controlled Trial
Official title: Applying Liquid Skin Barrier Film to Prevent Skin Complications Around Indwelling Vascular Catheters in Pediatric Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Injury
Skin Allergy
Keywords: Indwelling vascular catheters
Liquid skin barrier film
Wound dressing
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 120
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Long-term indwelling vascular catheters including central venous catheters, peripherally inserted central venous catheters, arterial catheters are often essential for medical care. During the routine care, some patients may experience skin damage around the catheter insertion site due to allergic reactions to the catheter dressing material, physical damage during dressing changes, leading to infection, prolonged hospitalization, and unexpected medical costs. If the condition is mild, it may increase the number of dressing changes. In severe cases, it may require changing to a different dressing method, using medication, or even removing the indwelling catheter. This study investigates the efficacy of liquid skin barrier film in preventing skin damage around long-term indwelling vascular catheters. In this randomized controlled trial, the participants aged 0 to less than 18 years who has long-term indwelling vascular catheters inserted at National Taiwan University Hospital Yunlin Branch will be recruited. At the time of indwelling vascular catheter insertion, the subjects are randomly assigned to the control group or the experimental group. The control group received standard care according to the hospital's guidelines, using a sterile transparent dressing or gauze to cover the catheter insertion site. The experimental group first applied liquid skin barrier film to the skin, then applied a sterile transparent dressing or gauze to cover the catheter insertion site. The patients are followed for two weeks. The primary endpoint is the need for change of dressing, use of medication, or removal of the catheter due to skin damage around the catheter insertion site. The secondary endpoints are skin breakdown, number of dressing changes, and incidence of bloodstream infection. It is expected that the research results may change the standard clinical management of long-term indwelling vascular catheters.


Eligibility criteria: Inclusion Criteria:

* Age 0-17 years (less than 18 years old)
* Receiving a central venous catheter, peripherally inserted central catheter, or arterial line insertion

Exclusion Criteria:

* The skin around the catheter insertion site is not inact
* Known allergic to liquid skin barrier film

Primary outcomes:
measure: Change of dressing method
timeFrame: 0-14 days
measure: Medical treatment for the skin
timeFrame: 0-14 days
measure: Vascular indwelling catheter removal
timeFrame: 0-14 days
Secondary outcomes:
measure: Occurrence of skin injury/allergy
timeFrame: 0-14 days
measure: Pain degree/severity of the skin
timeFrame: 0-14 days
measure: Number of dressing changes
timeFrame: 0-14 days
measure: Catheter-related bloodstream infection
timeFrame: 0-14 days
Other outcomes:
Locations:
city: Douliu
country: Taiwan
facility: National Taiwan University Hospital Yunlin Branch
state: Yunlin
Study officials:
affiliation: National Taiwan University Hospital Yunlin Branch
name: Hīng-Ka Lîm, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University
name: Ching-Ching Yang, RN
role: PRINCIPAL_INVESTIGATOR
References: