Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-01-03 @ 6:56 AM
Study NCT ID:
NCT03859232
Status:
WITHDRAWN
Last Update Posted:
2023-05-22
First Post:
2018-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Cotton vs. Waterproof Cast Padding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082602', 'term': 'Developmental Dysplasia of the Hip'}], 'ancestors': [{'id': 'D006617', 'term': 'Hip Dislocation'}, {'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Could not enroll participants', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-12-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-19', 'studyFirstSubmitDate': '2018-05-30', 'studyFirstSubmitQcDate': '2019-02-27', 'lastUpdatePostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness as a measure of change in ratings at different time points', 'timeFrame': 'Baseline, 2, 6 and 12 weeks post-application', 'description': 'The primary outcome (effectiveness) will be measured based on the change in ratings to the following variables/factors using a 10 point likert scale (1 being very poor and 10 being excellent):\n\nComfort, Ability for the cast to dry if it became wet, Cast odor, Cast durability, Protection from skin irritation, Ease of care in the cast, Ease of Application, Padding Aesthetics, Application Time, Skin Condition, Lack of Maceration / Excoriation, Cast Odor, Padding Condition, and Ease of Removal.\n\nThese will be collected at baseline, 2, 6 and 12 weeks post-application.'}], 'secondaryOutcomes': [{'measure': 'Quality', 'timeFrame': 'Baseline, 2, 6 and 12 weeks post-application', 'description': 'The secondary outcome (quality) will be measured based on rating to the following using a 10 point likert scale (1 being very poor and 10 being excellent):\n\nOverall Quality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Developmental Dysplasia of the Hip']}, 'descriptionModule': {'briefSummary': 'This study aims to: 1) investigate the effectiveness of waterproof spica cast using Delta-Dry® Pantaloon and cast padding (BSN medical, USA) versus standard gortex pantaloon with cotton cast padding in maintaining the femur fracture and developmental dysplasia of the hip reduction after application of hip spica; 2) evaluate the overall quality ratings of both cast paddings from the perspectives of the patient and the clinicians; and 3) determine the cost difference between the both cast paddings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Paediatric patients (\\<6 years old) diagnosed with developmental dysplasia of the hip or femur fracture who present to Texas Children's Hospital and plan to be treated with a spica cast.\n\nExclusion Criteria:\n\n* Patients with thigh diameter more than 13.4 inches will be excluded because of the size limitation of the Delta-Dry Pantaloon\n* Patients with femur fracture who present for treatment more than 2 weeks from the date of injury, comminuted fracture, non-displaced fracture, or with other surgical comorbidity"}, 'identificationModule': {'nctId': 'NCT03859232', 'briefTitle': 'Effectiveness of Cotton vs. Waterproof Cast Padding', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Effectiveness of Cotton vs. Waterproof Cast Padding After Application of Hip Spica: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'H-41712'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Delta Dry® Pantaloon Group', 'interventionNames': ['Other: Delta Dry® Waterproof Pantaloon']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cotton Padding Group', 'interventionNames': ['Other: Cotton Padding']}], 'interventions': [{'name': 'Delta Dry® Waterproof Pantaloon', 'type': 'OTHER', 'description': 'Cast with newer waterproof material developed to reduce the skin complications associated with traditional cotton liners.', 'armGroupLabels': ['Delta Dry® Pantaloon Group']}, {'name': 'Cotton Padding', 'type': 'OTHER', 'description': 'Cast with traditional cotton liner.', 'armGroupLabels': ['Cotton Padding Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Orthopaedic Surgery', 'investigatorFullName': 'Scott Rosenfeld', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}