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

NCT ID: NCT06192095

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Without skin barrier film

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

With skin barrier film

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

Group Type: EXPERIMENTAL

Skin barrier film

Intervention Type: DEVICE

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

Interventions

Skin barrier film

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

National Taiwan University Clinical Trial Center

National Taiwan University Hospital Yunlin Branch

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hīng-Ka Lîm, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Ching-Ching Yang, RN

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Locations

National Taiwan University Hospital Yunlin Branch

Douliu, Yunlin, Taiwan

Countries

Taiwan

Other Identifiers

NTUHYL 113-X015

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

202310113DIND

Identifier Type: -

Identifier Source: org_study_id