Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT01349894
Status:
WITHDRAWN
Last Update Posted:
2024-10-02
First Post:
2011-05-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SNaP Wound Care System Over Skin Cancer Excision Sites and Split Thickness Skin Grafts (STSGs)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study was terminated by Spiracur (original sponsor). Efforts were made to contact the PI/study team members, but were unsuccessful.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2011-05-05', 'studyFirstSubmitQcDate': '2011-05-06', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound Closure', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Split Thickness Skin Graft', 'Skin Cancer Excision Site', 'Skin Graft']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System for the treatment of skin cancer excision sites and split thickness skin grafts (STSG). The secondary purpose will be to compare the prospective patients to retrospectively treated skin cancer excision sites and STSGs to further evaluate efficacy and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will be selected from existing investigator patient population.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Skin cancer excision site and/or STSG as the source of the wound on any part of the body including head and neck, torso, and extremities. Any other type of skin graft will also be eligible for inclusion into the study.\n* Wound \\< 16 cm in greatest diameter\n* Subject ≥ 18 years of age\n* Female subjects of child-bearing potential must be willing to take a urine pregnancy test prior to starting study\n* Subject is willing and able to sign informed consent\n\nExclusion Criteria:\n\n* Wound-related cellulitis\n* Wound located in an area not amenable to forming an air-tight seal\n* Subject has untreated osteomyelitis\n* Subject is allergic to wound care products\n* Wound has exposed blood vessels not suitable for negative pressure therapy\n* Subject is actively participating in other clinical trials that conflict with current study\n* Subject has fistulas\n* Subject is pregnant'}, 'identificationModule': {'nctId': 'NCT01349894', 'briefTitle': 'SNaP Wound Care System Over Skin Cancer Excision Sites and Split Thickness Skin Grafts (STSGs)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solventum US LLC'}, 'officialTitle': 'Post-Market Clinical Evaluation of the Spiracur SNaP™ Wound Care System for Treatment of Skin Cancer Excision Sites and Split Thickness Skin Grafts', 'orgStudyIdInfo': {'id': '011111'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SNaP® Wound Care System', 'interventionNames': ['Device: SNaP® Wound Care System']}], 'interventions': [{'name': 'SNaP® Wound Care System', 'type': 'DEVICE', 'description': 'Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.', 'armGroupLabels': ['SNaP® Wound Care System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Dermatology and Plastic Surgery Institute, Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Francis Papay, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solventum US LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': '3M', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}