Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-11 @ 11:15 AM
Study NCT ID:
NCT01573234
Status:
COMPLETED
Last Update Posted:
2014-01-13
First Post:
2012-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of MySkin Patch for the Healing of Cut Injuries and Abrasions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057968', 'term': 'Transdermal Patch'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-10', 'studyFirstSubmitDate': '2012-04-02', 'studyFirstSubmitQcDate': '2012-04-06', 'lastUpdatePostDateStruct': {'date': '2014-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound healing', 'timeFrame': '1 month'}, {'measure': "Patient's pain", 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Clinical evaluation of the lesion scores for each visit', 'timeFrame': '1 month'}, {'measure': 'The presence / absence of infection for each visit', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['MySkin patch', 'Hydrogel bandage', 'Occlusive dressing'], 'conditions': ['Wounds and Injuries', 'Abrasion', 'Cut Injuries']}, 'descriptionModule': {'briefSummary': "Evaluation of clinical efficacy of My Skin (hydrogel and polyurethane film) plus best practice clinical care in subjects with cut injuries and abrasions with particular regard to: Wound healing (complete reepithelialization) and patient's pain.\n\nIn the context of the study will be collected secondary outcomes related to type of lesion and its clinical evolution through the analysis of the items in the scale of the Pressure Sore Status Tool(PSST)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of at least an injury cut or abrasion (even if sutured)covered by a dressing of 10x8 cm (80 cm2)\n* Injury treated with conventional dressings type gauze and patch\n* Patients assisted at the emergency care, or at the outpatient\n* Extension of the lesion less than 80 cm2 (including dressings in cm10x8cm)\n* Patient age greater than or equal to 18 years\n* Patients who have given consent to enrollment in the trial and the processing of personal data\n* Patient / lesion that has already been recruited in the study or who have previously passed a period of 10 days (wash-out) of "no treatment" according to the research protocol\n\nExclusion Criteria:\n\n* A end-stage of disease\n* Subjected systemic corticosteroid therapy / radiotherapy / immunosuppressive therapy\n* Suspected or known allergic diathesis to the product of medication\n* Subjects that do not give consent to data processing\n* Dry lesion with necrosis or eschar\n* Presence of both local and systemic infection or inflammation\n* Injuries that to the decision of the provider of care, needs a targeted local treatment other than as provided for in the Protocol\n* Patient / lesion that has already been previously recruited into the study, before a period of 10 days (wash-out) of suspension from the same research protocol'}, 'identificationModule': {'nctId': 'NCT01573234', 'briefTitle': 'Efficacy of MySkin Patch for the Healing of Cut Injuries and Abrasions', 'organization': {'class': 'OTHER', 'fullName': 'Associazione Infermieristica per lo studio delle Lesioni Cutanee'}, 'officialTitle': 'Efficacy of MySkin Patch for the Healing of Cut Injuries and Abrasions: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'AISLeC-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MySkin patch', 'description': 'Hydrogel and polyurethane film', 'interventionNames': ['Device: MySkin patch']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional Dressing', 'interventionNames': ['Device: Gauze and Patch']}], 'interventions': [{'name': 'MySkin patch', 'type': 'DEVICE', 'description': 'Hydrogel and polyurethane film', 'armGroupLabels': ['MySkin patch']}, {'name': 'Gauze and Patch', 'type': 'DEVICE', 'description': 'Traditional Dressing', 'armGroupLabels': ['Traditional Dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40100', 'city': 'Bologna', 'state': 'Bologna', 'country': 'Italy', 'facility': 'Ospedale Bellaria - UOC Dermatologia', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Tommaso Bianchi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Associazione Infermieristica per lo studio delle Lesioni Cutanee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Associazione Infermieristica per lo studio delle Lesioni Cutanee', 'class': 'OTHER'}, 'collaborators': [{'name': 'Artsana S.p.a.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}