Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-29 @ 12:08 PM
Study NCT ID:
NCT07175116
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advanced Dressings for CVC Infection Prevention in PICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055499', 'term': 'Catheter-Related Infections'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'This was a single-blind trial. The outcomes assessor was blinded to group allocation. Participants and care providers were aware of the dressing used'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2025-09-05', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of central venous catheter-related bloodstream infection (CVC-BSI)', 'timeFrame': 'Baseline to 4 weeks or until catheter removal', 'description': 'CVC-BSI confirmed by clinical signs and positive blood culture according to Bacteriemia Zero protocol.'}], 'secondaryOutcomes': [{'measure': 'Catheter colonisation rate', 'timeFrame': 'At catheter removal (up to 14 days after insertion)', 'description': 'Positive culture of catheter tip (\\>15 CFU/mL) according to standard microbiological protocol.'}, {'measure': 'Skin complications at insertion site', 'timeFrame': 'Up to 4 weeks', 'description': 'Erythema, pruritus or dermatitis at the catheter insertion site documented by clinical observation.'}, {'measure': 'Number of dressing changes per patient', 'timeFrame': 'Up to 4 weeks', 'description': 'Total number of dressing replacements per patient recorded during catheterisation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Catheter-Related Infections', 'Central Venous Catheters', 'Bloodstream Infection', 'Pediatric Intensive Care Units']}, 'descriptionModule': {'briefSummary': 'Randomised, single-blind clinical trial comparing chlorhexidine gluconate-impregnated transparent dressings versus conventional transparent dressings in the prevention of central venous catheter-related bloodstream infections (CVC-BSI) in paediatric patients admitted to a tertiary hospital PICU. Outcomes include incidence of BRCVC, catheter colonisation, dressing-related skin complications, and number of dressing changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission to paediatric intensive care unit (PICU)\n* Central venous catheter placement (central or peripherally inserted)\n* Informed consent obtained from parent/legal guardian\n\nExclusion Criteria:\n\n* Known immunological disorders\n* Neutropenia (\\<500/mm³)\n* Pre-existing colonisation or infection with multidrug-resistant organisms'}, 'identificationModule': {'nctId': 'NCT07175116', 'briefTitle': 'Advanced Dressings for CVC Infection Prevention in PICU', 'organization': {'class': 'OTHER', 'fullName': 'University of Seville'}, 'officialTitle': 'Use of Advanced Fixation Dressings in Reducing Central Venous Catheter-related Bloodstream Infections in a Paediatric Intensive Care Unit', 'orgStudyIdInfo': {'id': 'US-PICU-CV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental - Chlorhexidine gluconate-impregnated dressing', 'description': 'Participants receive advanced transparent dressings impregnated with chlorhexidine gluconate at the CVC insertion site.', 'interventionNames': ['Device: 3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control - Conventional transparent dressing', 'description': 'Participants receive standard transparent polyurethane dressing without antimicrobial activity at the CVC insertion site.', 'interventionNames': ['Device: Conventional transparent polyurethane dressing']}], 'interventions': [{'name': '3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated)', 'type': 'DEVICE', 'description': 'Individually applied transparent dressing containing chlorhexidine gluconate (0.5-1 mg/cm²) for antimicrobial protection at the central venous catheter insertion site. The dressing maintains site visibility, reduces catheter manipulation frequency, and provides sustained release of chlorhexidine to lower colonisation and bloodstream infection risk.', 'armGroupLabels': ['Experimental - Chlorhexidine gluconate-impregnated dressing']}, {'name': 'Conventional transparent polyurethane dressing', 'type': 'DEVICE', 'description': 'Transparent polyurethane dressing without antimicrobial impregnation, applied at the central venous catheter insertion site. This dressing allows site inspection and is widely used in standard paediatric intensive care protocols but provides no antimicrobial activity.', 'armGroupLabels': ['Control - Conventional transparent dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41004', 'city': 'Seville', 'state': 'Sevilla', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Manuel Pabón-Carrasco', 'role': 'CONTACT', 'email': 'mpabon2@us.es'}], 'facility': 'Hospital Universitario Virgen del Rocío - Hospital Infantil', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Manuel Pabón-Carrasco', 'role': 'CONTACT', 'email': 'mpabon2@us.es', 'phone': '+34 669709548'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Seville', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospitales Universitarios Virgen del Rocío', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville', 'investigatorFullName': 'MANUEL PABON CARRASCO', 'investigatorAffiliation': 'University of Seville'}}}}