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

NCT06192095 | Completed

• 2 other identifiers: 202310113DINDNTUHYL 113-X015
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Injury; Skin Allergy

Keywords

Indwelling vascular catheters; Liquid skin barrier film; Wound dressing

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Occurrence of skin injury/allergy

  0-14 days

• Pain degree/severity of the skin

  0-14 days

• Number of dressing changes

  0-14 days

• Catheter-related bloodstream infection

  0-14 days

Study Arms (2)

Without skin barrier film

NO INTERVENTION

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

With skin barrier film

EXPERIMENTAL

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

Device: Skin barrier film

Interventions

Skin barrier film DEVICE

Preventive use of skin barrier film after insertion of a vascular indwelling catheter before covering with transparent dressing +/- gauze

With skin barrier film

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Yunlin Branch

Douliu, Yunlin, 640, Taiwan

Location

Study Officials

• Hīng-Ka Lîm, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Ching-Ching Yang, RN

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National Taiwan University Hospital Yunlin Branch

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 20, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)