Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-01-03 @ 8:15 PM
Study NCT ID:
NCT03628495
Status:
UNKNOWN
Last Update Posted:
2018-08-14
First Post:
2018-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Combined Pressure and Silicone Intervention for Hypertrophic Scar Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017439', 'term': 'Cicatrix, Hypertrophic'}], 'ancestors': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003766', 'term': 'Dental Occlusion'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The ultrasound data will be processed and the data will be analysed by analysts who are blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2018-05-23', 'studyFirstSubmitQcDate': '2018-08-09', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline HS thickness at 6 months', 'timeFrame': 'at baseline, one and six month after treatment', 'description': 'HS thickness measured by the Diagnostic Ultrasound System'}], 'secondaryOutcomes': [{'measure': 'Change from baseline HS color at 6 months', 'timeFrame': 'at baseline, one and six month after treatment', 'description': 'HS color measured by the DermaLab Combo Color measurement'}, {'measure': 'Change from baseline HS pliability at 6 months', 'timeFrame': 'at baseline, one and six month after treatment', 'description': 'HS pliability measured by the DermaLab Combo elasticity measurement'}, {'measure': 'Change from baseline HS hydration at 6 months', 'timeFrame': 'at baseline, one and six month after treatment', 'description': 'HS hydration measured by the DermaLab Combo hydration measurement'}, {'measure': 'Itchiness', 'timeFrame': 'at baseline, one and six month after treatment', 'description': 'HS Itchiness measured by the Numerical rating scale'}, {'measure': 'QoL', 'timeFrame': 'at baseline, one and six month after treatment', 'description': 'SF-36 will be used to measure the Quality of Life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['insert', 'pressure therapy', 'silicone gel'], 'conditions': ['Cicatrix, Hypertrophic', 'Rehabilitation']}, 'descriptionModule': {'briefSummary': 'Pressure therapy (PT) and silicone therapy are recommended as first-line non-invasive treatments HS, yet the effectiveness of the combination of these two treatments through an RCT trial has not been established yet. This study aims to examine the effectiveness of the combination of adequate pressure therapy and silicone gel sheeting implemented by Smart Scar Care Pad (SSCP) + Smart Pressure Monitored Suit (SPMS) versus conventional Pressure Garment (PG in the management of severe HS in adult. It is hypothesized that the combination of adequate pressure therapy and silicone gel sheeting will demonstrate its superiority in improving scar parameters than conventional pressure garment therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The Vancouver Scar Scale (VSS) will be used to screen candidates for the study.10 Isolated scars with a total score of 4 or higher and the score of each item equal to or greater than 1 will be included.\n* The scar size should also reach 2\\*2 cm2 or above to allow adequate area for assessment tool attachement.\n* Consenting adult's age between 19 to 60 years old who is able to provide written consent, cooperative, and good compliance with treatment.\n\nExclusion Criteria:\n\n* the HS area have an open wound or infection;\n* the HS have been treated with steroid injections or other intervention (such as traditional Chinese medicine or laser therapy) prior to the study;\n* the patients have a medical condition that might affect wound healing (e.g., diabetes mellitus or another serious medical problem);\n* the patients with comorbidities that might affect their compliance to treatment: such as severe scar contracture at adjacent area that might be scheduled for reconstructive surgery."}, 'identificationModule': {'nctId': 'NCT03628495', 'briefTitle': 'Effectiveness of a Combined Pressure and Silicone Intervention for Hypertrophic Scar Treatment', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Effectiveness of a Combined Adequate Pressure and Silicone Intervention in Comparison With Conventional Pressure Therapy for Hypertrophic Scar Treatment: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HSEARS20160418002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SSCP + SPMS', 'interventionNames': ['Device: compression', 'Device: occlusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PG', 'interventionNames': ['Device: compression']}], 'interventions': [{'name': 'compression', 'type': 'DEVICE', 'description': 'compression will be delivered using compression garment', 'armGroupLabels': ['PG', 'SSCP + SPMS']}, {'name': 'occlusion', 'type': 'DEVICE', 'description': 'occlusion will be delivered using silicone gel sheeting', 'armGroupLabels': ['SSCP + SPMS']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Cecilia Li, PhD', 'role': 'CONTACT', 'email': 'cecilia.li@polyu.edu.hk', 'phone': '852-27666715'}], 'overallOfficials': [{'name': 'Cecilia Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}