Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-27 @ 10:44 PM
Study NCT ID:
NCT06192095
Status:
COMPLETED
Last Update Posted:
2025-01-20
First Post:
2023-12-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Applying Liquid Skin Barrier Film to Prevent Skin Complications Around Indwelling Vascular Catheters in Pediatric Patients: a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2023-12-20', 'studyFirstSubmitQcDate': '2023-12-20', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of dressing method', 'timeFrame': '0-14 days', 'description': 'Change of dressing method due to injury/allergy of skin around the vascular indwelling catheters'}, {'measure': 'Medical treatment for the skin', 'timeFrame': '0-14 days', 'description': 'Need of medical treatment (topical, oral, intravenous) due to injury/allergy of skin around the vascular indwelling catheters'}, {'measure': 'Vascular indwelling catheter removal', 'timeFrame': '0-14 days', 'description': 'Need of catheter removal due to injury/allergy of skin around'}], 'secondaryOutcomes': [{'measure': 'Occurrence of skin injury/allergy', 'timeFrame': '0-14 days', 'description': 'Skin injury/allergy of the skin around the vascular indwelling catheter'}, {'measure': 'Pain degree/severity of the skin', 'timeFrame': '0-14 days', 'description': 'Pain degree of the skin around the vascular indwelling catheter'}, {'measure': 'Number of dressing changes', 'timeFrame': '0-14 days', 'description': 'Total number of dressing changes of the vascular indwelling catheter'}, {'measure': 'Catheter-related bloodstream infection', 'timeFrame': '0-14 days', 'description': 'Occurrence of catheter-related bloodstream infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Indwelling vascular catheters', 'Liquid skin barrier film', 'Wound dressing'], 'conditions': ['Skin Injury', 'Skin Allergy']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 0-17 years (less than 18 years old)\n* Receiving a central venous catheter, peripherally inserted central catheter, or arterial line insertion\n\nExclusion Criteria:\n\n* The skin around the catheter insertion site is not inact\n* Known allergic to liquid skin barrier film'}, 'identificationModule': {'nctId': 'NCT06192095', 'briefTitle': 'Applying Liquid Skin Barrier Film to Prevent Skin Complications Around Indwelling Vascular Catheters in Pediatric Patients: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Applying Liquid Skin Barrier Film to Prevent Skin Complications Around Indwelling Vascular Catheters in Pediatric Patients: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '202310113DIND'}, 'secondaryIdInfos': [{'id': 'NTUHYL 113-X015', 'type': 'OTHER_GRANT', 'domain': 'National Taiwan University Hospital Yunlin Branch'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Without skin barrier film', 'description': 'Routine care without skin barrier film around the insertion site of a vascular indwelling catheter'}, {'type': 'EXPERIMENTAL', 'label': 'With skin barrier film', 'description': 'Routine care with preventive use of skin barrier film around the insertion site of a vascular indwelling catheter', 'interventionNames': ['Device: Skin barrier film']}], 'interventions': [{'name': 'Skin barrier film', 'type': 'DEVICE', 'description': 'Preventive use of skin barrier film after insertion of a vascular indwelling catheter before covering with transparent dressing +/- gauze', 'armGroupLabels': ['With skin barrier film']}]}, 'contactsLocationsModule': {'locations': [{'zip': '640', 'city': 'Douliu', 'state': 'Yunlin', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital Yunlin Branch', 'geoPoint': {'lat': 23.70944, 'lon': 120.54333}}], 'overallOfficials': [{'name': 'Hīng-Ka Lîm, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}, {'name': 'Ching-Ching Yang, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'National Taiwan University Hospital Yunlin Branch', 'investigatorFullName': 'National Taiwan University Clinical Trial Center', 'investigatorAffiliation': 'National Taiwan University Hospital'}}}}