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NCT Number: NCT06192095

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.

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Key information

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital Yunlin Branch

Douliu, Yunlin, 640, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skin barrier film

Device

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

Primary outcomes

  1. Change of dressing method

    Time frame: 0-14 days

    Change of dressing method due to injury/allergy of skin around the vascular indwelling catheters

  2. Medical treatment for the skin

    Time frame: 0-14 days

    Need of medical treatment (topical, oral, intravenous) due to injury/allergy of skin around the vascular indwelling catheters

  3. Vascular indwelling catheter removal

    Time frame: 0-14 days

    Need of catheter removal due to injury/allergy of skin around

Secondary outcomes

  1. Occurrence of skin injury/allergy

    Time frame: 0-14 days

    Skin injury/allergy of the skin around the vascular indwelling catheter

  2. Pain degree/severity of the skin

    Time frame: 0-14 days

    Pain degree of the skin around the vascular indwelling catheter

  3. Number of dressing changes

    Time frame: 0-14 days

    Total number of dressing changes of the vascular indwelling catheter

  4. Catheter-related bloodstream infection

    Time frame: 0-14 days

    Occurrence of catheter-related bloodstream infection

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 5, 2024
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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