Applying Liquid Skin Barrier Film to Prevent Skin Complications Around Indwelling Vascular Catheters in Pediatric Patients: a Randomized Controlled Trial

National Taiwan University

Status: Completed

Conditions: Skin Injury; Skin Allergy

Treatments: Device: Skin barrier film

Study type: Interventional

Funder types: Other

Identifiers

NCT06192095

202310113DIND

NTUHYL 113-X015 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Without skin barrier film

No Intervention group

Description:

Routine care without skin barrier film around the insertion site of a vascular indwelling catheter

With skin barrier film

Experimental group

Description:

Routine care with preventive use of skin barrier film around the insertion site of a vascular indwelling catheter

Treatment:

Device: Skin barrier film