Skin InjuryNCT06192095
Applying Liquid Skin Barrier Film to Prevent Skin Complications Around Indwelling Vascular Catheters in Pediatric Patients: a Randomized Controlled Trial
A study testing Skin barrier film in people with Skin Injury and Skin Allergy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Long-term indwelling vascular catheters including central venous catheters, peripherally inserted central venous catheters, arterial catheters are often essential for medical care. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Skin Injury, Skin Allergy
- What is being tested?
- Skin barrier film
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 0-17 years (less than 18 years old)
- Receiving a central venous catheter, peripherally inserted central catheter, or arterial line insertion
Who cannot join
- The skin around the catheter insertion site is not inact
- Known allergic to liquid skin barrier film
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital Yunlin Branch
Douliu, Yunlin, 640
About this study
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
- Being tested
- Skin barrier film
- Keywords
- Indwelling vascular catheters, Liquid skin barrier film, Wound dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin barrier filmDevice
Preventive use of skin barrier film after insertion of a vascular indwelling catheter before covering with transparent dressing +/- gauze
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Skin barrier film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of dressing method
Change of dressing method due to injury/allergy of skin around the vascular indwelling catheters
Measured: 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
Measured: 0-14 days
Vascular indwelling catheter removal
Need of catheter removal due to injury/allergy of skin around
Measured: 0-14 days
Secondary outcomes (4)
Occurrence of skin injury/allergy
Skin injury/allergy of the skin around the vascular indwelling catheter
Measured: 0-14 days
Pain degree/severity of the skin
Pain degree of the skin around the vascular indwelling catheter
Measured: 0-14 days
Number of dressing changes
Total number of dressing changes of the vascular indwelling catheter
Measured: 0-14 days
Catheter-related bloodstream infection
Occurrence of catheter-related bloodstream infection
Measured: 0-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin InjuryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
- Investigators
- Hīng-Ka Lîm, MD, PhD, Principal investigator, National Taiwan University HospitalChing-Ching Yang, RN, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192095
- Sponsor's protocol ID
- 202310113DIND
- Other IDs
- NTUHYL 113-X015
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2023
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Liquid Skin Barrier Film to Prevent Skin Complications Around Indwelling Vascular Catheters in Pediatric Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06192095
- Acronym / sponsor ID
- 202310113DIND
- Conditions
- Skin Injury, Skin Allergy
- Keywords
- Indwelling vascular catheters, Liquid skin barrier film, Wound dressing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Skin barrier filmRoutine care with preventive use of skin barrier film around the insertion site of a vascular indwelling catheter |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 0-17 years (less than 18 years old)
- Receiving a central venous catheter, peripherally inserted central catheter, or arterial line insertion
Key exclusion criteria (2 listed)
- The skin around the catheter insertion site is not inact
- Known allergic to liquid skin barrier film
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin barrier filmPreventive use of skin barrier film after insertion of a vascular indwelling catheter before covering with transparent dressing +/- gauze | Device | With skin barrier film |
Primary outcome
Change of dressing method
Time frame: 0-14 days
Change of dressing method due to injury/allergy of skin around the vascular indwelling catheters
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
Vascular indwelling catheter removal
Time frame: 0-14 days
Need of catheter removal due to injury/allergy of skin around
4 secondary outcomes
Occurrence of skin injury/allergy
Time frame: 0-14 days
Pain degree/severity of the skin
Time frame: 0-14 days
Number of dressing changes
Time frame: 0-14 days
Catheter-related bloodstream infection
Time frame: 0-14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hīng-Ka Lîm, MD, PhD principal investigator
National Taiwan University Hospital
Ching-Ching Yang, RN principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin barrier film in people with Skin Injury and Skin Allergy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of dressing method (time frame: 0-14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.