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

Last updated: January 17, 2025
Sponsor: National Taiwan University Hospital
Overall Status: Completed

Phase

N/A

Condition

Allergy

Urticaria

Pressure Ulcer

Treatment

Skin barrier film

Clinical Study ID

NCT06192095
202310113DIND
NTUHYL 113-X015
  • Ages < 17
  • All Genders

Study 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

Inclusion Criteria:

  • Age 0-17 years (less than 18 years old)

  • Receiving a central venous catheter, peripherally inserted central catheter, orarterial line insertion

Exclusion

Exclusion Criteria:

  • The skin around the catheter insertion site is not inact

  • Known allergic to liquid skin barrier film

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Skin barrier film
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • National Taiwan University Hospital Yunlin Branch

    Douliu, Yunlin 640
    Taiwan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.