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| ID | Type | Description | Link |
|---|---|---|---|
| NTUHYL 113-X015 | Other Grant/Funding Number | National Taiwan University Hospital Yunlin Branch |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin barrier film | Device | Preventive use of skin barrier film after insertion of a vascular indwelling catheter before covering with transparent dressing +/- gauze |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of skin injury/allergy | Skin injury/allergy of the skin around the vascular indwelling catheter | 0-14 days |
| Pain degree/severity of the skin | Pain degree of the skin around the vascular indwelling catheter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hīng-Ka Lîm, MD, PhD | National Taiwan University Hospital | Principal Investigator |
| Ching-Ching Yang, RN | National Taiwan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital Yunlin Branch | Douliu | Yunlin | 640 | Taiwan |
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| 0-14 days |
| Number of dressing changes | Total number of dressing changes of the vascular indwelling catheter | 0-14 days |
| Catheter-related bloodstream infection | Occurrence of catheter-related bloodstream infection | 0-14 days |