Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:48 AM
Study NCT ID:
NCT07392294
Status:
COMPLETED
Last Update Posted:
2026-02-06
First Post:
2026-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Foam Dressing Versus Silver Foam Dressing for Pediatric Tracheostomy Wound Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}, {'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-30', 'studyFirstSubmitDate': '2026-01-30', 'studyFirstSubmitQcDate': '2026-01-30', 'lastUpdatePostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Peristomal Complications', 'timeFrame': '30 days postoperatively', 'description': 'Measure DescriptionOverall rate of peristomal complications including infection, pressure ulcer, granulation tissue, and skin necrosis. Measured as percentage of patients developing any complication.'}], 'secondaryOutcomes': [{'measure': 'Braden Q Risk Assessment Scale Score', 'timeFrame': 'Postoperative days 1, 7, 14, and 21', 'description': 'Measure DescriptionPressure ulcer risk assessment using Braden Q Scale (score range 7-28). Lower scores indicate higher risk: ≤12 high risk, 13-15 moderate risk, ≥16 no risk.'}, {'measure': 'Pressure Ulcer Severity by NPIAP Classification', 'timeFrame': '30 days postoperatively', 'description': 'Measure DescriptionPressure ulcer staging according to National Pressure Injury Advisory Panel (NPIAP) classification system: Stage 1 (non-blanchable erythema), Stage 2 (partial-thickness skin loss), Stage 3 (full-thickness skin loss), Stage 4 (full-thickness tissue loss).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric tracheostomy', 'Foam dressing', 'Silver-impregnated dressing', 'Pressure ulcer prevention', 'Peristomal complications', 'Wound care', 'Braden Q Scale', 'Children'], 'conditions': ['Tracheostomy Complication', 'Pressure Ulcer (PU)', 'Surgical Wound']}, 'descriptionModule': {'briefSummary': 'This study compares two types of wound dressings used after tracheostomy surgery in children: standard foam dressing and silver-impregnated foam dressing.\n\nTracheostomy is a surgical procedure that creates an opening in the neck to help children breathe. Skin problems around the tracheostomy site are common, occurring in up to 29% of pediatric patients.\n\nThe purpose of this study is to determine if silver-impregnated foam dressing is better than standard foam dressing in preventing skin complications around the tracheostomy site.\n\nFifty children (ages 0-18 years) undergoing tracheostomy surgery were randomly assigned to receive either standard foam dressing or silver-impregnated foam dressing. All patients received the same standardized wound care. Patients were followed for one month after surgery.\n\nThe main outcome measured was the rate of skin complications. Secondary outcomes included pressure ulcer risk assessment using the Braden Q Scale and wound staging using the National Pressure Injury Advisory Panel classification.', 'detailedDescription': 'Peristomal skin complications represent a significant concern following pediatric tracheostomy, with reported incidence rates up to 29%. These complications include pressure ulcers, infections, granulation tissue, and skin breakdown.\n\nThis prospective randomized controlled trial was conducted at a single tertiary care center. Fifty pediatric patients undergoing elective tracheostomy were enrolled and randomly assigned to one of two groups:\n\nGroup A (n=25): Standard foam dressing Group B (n=25): Silver-impregnated foam dressing\n\nAll patients received a standardized postoperative care protocol including:\n\n* Velcro ties with foam padding for tube securement\n* Daily wound assessment\n* Neutral head positioning for ventilated patients\n* Standardized dressing change criteria\n\nPatients were assessed on postoperative days 1, 7, 14, 21, and 30. Pressure ulcer risk was evaluated using the Braden Q Risk Assessment Scale, and any pressure injuries were staged according to the National Pressure Injury Advisory Panel (NPIAP) classification system.\n\nThis is the first randomized controlled trial comparing these dressing types using validated, standardized assessment tools in pediatric tracheostomy patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients aged 0-18 years\n* Undergoing elective tracheostomy\n* Tracheostomy performed by the pediatric otolaryngology team\n* Followed in neonatal or pediatric intensive care units\n\nExclusion Criteria:\n\n* Patients over 18 years of age\n* Emergency tracheostomy\n* Percutaneous tracheostomy\n* Pre-existing skin diseases\n* History of head and neck surgery\n* Tracheostomy performed during airway reconstruction surgery'}, 'identificationModule': {'nctId': 'NCT07392294', 'briefTitle': 'Foam Dressing Versus Silver Foam Dressing for Pediatric Tracheostomy Wound Care', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem Atasehir Hospital'}, 'officialTitle': 'Comparison of Foam Dressing Versus Silver-Impregnated Foam Dressing for Prevention of Peristomal Complications in Pediatric Tracheostomy: A Prospective Randomized Controlled Trial Using Validated Assessment Tools', 'orgStudyIdInfo': {'id': '85-2021'}, 'secondaryIdInfos': [{'id': '2022/001).', 'type': 'OTHER_GRANT', 'domain': 'Science Research Program of Health Sciences University.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Foam Dressing', 'description': 'Patients received standard foam dressing for tracheostomy wound care (Group A, n=25)', 'interventionNames': ['Device: Standard Foam Dressing']}, {'type': 'EXPERIMENTAL', 'label': 'Silver-Impregnated Foam Dressing', 'description': 'Patients received silver-impregnated foam dressing for tracheostomy wound care (Group B, n=25)', 'interventionNames': ['Device: Silver-Impregnated Foam Dressing']}], 'interventions': [{'name': 'Standard Foam Dressing', 'type': 'DEVICE', 'description': 'DescriptionStandard foam dressing applied under tracheostomy cannula. Dressings were changed when 75% saturated with secretions or left in place up to 7 days if dry.', 'armGroupLabels': ['Standard Foam Dressing']}, {'name': 'Silver-Impregnated Foam Dressing', 'type': 'DEVICE', 'description': 'Silver-impregnated foam dressing applied under tracheostomy cannula. Dressings were changed when 75% saturated with secretions or left in place up to 7 days if dry.', 'armGroupLabels': ['Silver-Impregnated Foam Dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34660', 'city': 'Istanbul', 'state': 'Ataturk Mahallesi', 'country': 'Turkey (Türkiye)', 'facility': 'Acibadem Atasehir Hastanesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Asli SAHIN YILMAZ, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Umraniye Education and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem Atasehir Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'SERAP SAHIN ONDER', 'investigatorAffiliation': 'Acibadem Atasehir Hospital'}}}}