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

Skin Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06192095
• Other study ID #: 202310113DIND
• Secondary ID: NTUHYL 113-X015
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: National Taiwan University Hospital
• Contact: Hing-Ka Lîm, MD, PhD
• Phone: +88655323911
• Email: linhsinchia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Injury

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Yunlin Branch	Douliu	Yunlin

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of dressing method	Change of dressing method due to injury/allergy of skin around the vascular indwelling catheters	0-14 days
Primary	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
Primary	Vascular indwelling catheter removal	Need of catheter removal due to injury/allergy of skin around	0-14 days
Secondary	Occurrence of skin injury/allergy	Skin injury/allergy of the skin around the vascular indwelling catheter	0-14 days
Secondary	Pain degree/severity of the skin	Pain degree of the skin around the vascular indwelling catheter	0-14 days
Secondary	Number of dressing changes	Total number of dressing changes of the vascular indwelling catheter	0-14 days
Secondary	Catheter-related bloodstream infection	Occurrence of catheter-related bloodstream infection	0-14 days