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

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.

Study Overview

• Status: Completed
• Conditions: Skin Injury; Skin Allergy
• Intervention / Treatment: Device: Skin barrier film

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Yunlin
    • Douliu, Yunlin, Taiwan, 640
      • National Taiwan University Hospital Yunlin Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Without skin barrier film; Routine care without skin barrier film around the insertion site of a vascular indwelling catheter
Experimental: With skin barrier film; Routine care with preventive use of skin barrier film around the insertion site of a vascular indwelling catheter	Device: Skin barrier film; Preventive use of skin barrier film after insertion of a vascular indwelling catheter before covering with transparent dressing +/- gauze

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of dressing method	Change of dressing method due to injury/allergy of skin around the vascular indwelling catheters	0-14 days
Medical treatment for the skin	Need of medical treatment (topical, oral, intravenous) due to injury/allergy of skin around the vascular indwelling catheters	0-14 days
Vascular indwelling catheter removal	Need of catheter removal due to injury/allergy of skin around	0-14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of skin injury/allergy	Skin injury/allergy of the skin around the vascular indwelling catheter	0-14 days
Pain degree/severity of the skin	Pain degree of the skin around the vascular indwelling catheter	0-14 days
Number of dressing changes	Total number of dressing changes of the vascular indwelling catheter	0-14 days
Catheter-related bloodstream infection	Occurrence of catheter-related bloodstream infection	0-14 days

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Hīng-Ka Lîm, MD, PhD, National Taiwan University Hospital Yunlin Branch; Principal Investigator: Ching-Ching Yang, RN, National Taiwan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Wound dressing; Indwelling vascular catheters; Liquid skin barrier film
• Other Study ID Numbers: 202310113DIND; NTUHYL 113-X015 (Other Grant/Funding Number: National Taiwan University Hospital Yunlin Branch)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No