Applying Liquid Skin Barrier Film to Prevent Skin Complications Around Indwelling Vascular Catheters in Pediatric Patients: a Randomized Controlled Trial
- Conditions
- Skin InjurySkin Allergy
- Interventions
- Device: Skin barrier film
- Registration Number
- NCT06192095
- Lead Sponsor
- National Taiwan University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Age 0-17 years (less than 18 years old)
- Receiving a central venous catheter, peripherally inserted central catheter, or arterial line insertion
- The skin around the catheter insertion site is not inact
- Known allergic to liquid skin barrier film
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description With skin barrier film Skin barrier film Routine care with preventive use of skin barrier film around the insertion site of a vascular indwelling catheter
- Primary Outcome Measures
Name Time Method Change of dressing method 0-14 days Change of dressing method due to injury/allergy of skin around the vascular indwelling catheters
Vascular indwelling catheter removal 0-14 days Need of catheter removal due to injury/allergy of skin around
Medical treatment for the skin 0-14 days Need of medical treatment (topical, oral, intravenous) due to injury/allergy of skin around the vascular indwelling catheters
- Secondary Outcome Measures
Name Time Method Catheter-related bloodstream infection 0-14 days Occurrence of catheter-related bloodstream infection
Pain degree/severity of the skin 0-14 days Pain degree of the skin around the vascular indwelling catheter
Occurrence of skin injury/allergy 0-14 days Skin injury/allergy of the skin around the vascular indwelling catheter
Number of dressing changes 0-14 days Total number of dressing changes of the vascular indwelling catheter
Trial Locations
- Locations (1)
National Taiwan University Hospital Yunlin Branch
🇨🇳Douliu, Yunlin, Taiwan