Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-27 @ 12:36 PM
Study NCT ID:
NCT05748392
Status:
WITHDRAWN
Last Update Posted:
2024-10-01
First Post:
2023-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3M Veraflo™ Cleanse Choice Complete™ (VFCCC) Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No longer required.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-27', 'studyFirstSubmitDate': '2023-02-14', 'studyFirstSubmitQcDate': '2023-02-27', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Debridement', 'timeFrame': 'Up to 14 days', 'description': 'Subject incidence of bedside debridement.\n\n* Subject incidence of operating room debridement.\n* Number of avoided debridement procedures in the operating room based on physician assessment.'}], 'primaryOutcomes': [{'measure': 'ADE/SADE', 'timeFrame': 'Up to 14 days', 'description': 'Subject incidence of Adverse Device Events (ADEs) and Serious ADEs (SADEs) during the use of the device.'}], 'secondaryOutcomes': [{'measure': 'Total Wound Area (%)', 'timeFrame': 'Up to 14 days', 'description': 'Percent change in total wound area (%) from baseline to end-of-study.'}, {'measure': 'Non-viable Tissue (%)', 'timeFrame': 'Up to 14 days', 'description': 'Change in the percentage of non-viable tissue from baseline to end-of-study.'}, {'measure': 'Total Wound Volume (%)', 'timeFrame': 'Up to 14 days', 'description': 'Change in the percentage of total wound volume (%) from baseline to end-of-study.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['WOUNDS INJURIES']}, 'descriptionModule': {'briefSummary': 'The purpose of this external clinical study is to demonstrate the safety and performance of the Veraflo™ Cleanse Choice Complete™ Dressing Kit which will be used in conjunction with the V.A.C.® Ulta™ Therapy Unit, utilizing V.A.C. Veraflo™ Therapy instillation functions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Subject is at least 22 years old at time of consent.\n* Subject OR Legal Authorized Representative is able to provide informed consent.\n* Subject has been confirmed to have a chronic, acute, traumatic, sub-acute, or dehisced wound, partial-thickness burn, ulcer (such as diabetic, pressure or venous insufficiency), flap or graft.\n\nExclusion Criteria:\n\n* Subject is pregnant prior to application of the initial dressing\\*\n\n \\*Women who have had surgical sterilization by a medically accepted method (i.e. tubal ligation, hysterectomy, or oophorectomy) or are post-menopausal, defined as not having menstruation for \\> 12 months will not be required to undergo pregnancy testing.\n* Subject has been diagnosed with a malignancy in the wound.\n* Subject has untreated osteomyelitis.\n* Subject has an untreated systemic infection.\n* Subject has active cellulitis in the peri-wound area.\n* Subject has a known allergy or hypersensitivity to study materials: dressing(s), and/or dressing components such as acrylic or silicone adhesives or polyurethane.\n* Subject has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures.\n* Subject has had radiation directly to the wound area.\n* Subject has been diagnosed with a major vascular deficit limiting arterial inflow to the wound region, as determined by the Investigator's interpretation of the Subject's medical history.\n* Subject has necrotic tissue with eschar present. NOTE: After debridement of necrotic tissue and complete removal of eschar, Veraflo™ Therapy may be used.\n* Subject is participating in another interventional clinical study or was enrolled in a clinical trial within the last 30 days of Visit 1.\n* Subject has non-enteric or unexplored fistula.\n* Subject has a wound with any unexplored tunneling present.\n* Subject has inadequate hemostasis at the wound site, as determined by the investigator.\n* Subject has a wound with non-protected exposed vessels, anastomotic sites, organ, or nerves."}, 'identificationModule': {'nctId': 'NCT05748392', 'briefTitle': '3M Veraflo™ Cleanse Choice Complete™ (VFCCC) Clinical Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solventum US LLC'}, 'officialTitle': 'A Post-market, Multicenter, Prospective, Single-arm Study Evaluating Safety and Performance of the Veraflo™ Cleanse Choice Complete™ Dressing', 'orgStudyIdInfo': {'id': '05-015054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Veraflo™ Cleanse Choice Complete™ Dressing Use with Assessments', 'description': 'Subject will have Veraflo™ Cleanse Choice Complete™ dressing applied and used per instructions for use. 3D imaging and wound / peri-wound skin characteristics will be taken during the treatment.', 'interventionNames': ['Device: Wound and per-wound assessments While using Device']}], 'interventions': [{'name': 'Wound and per-wound assessments While using Device', 'type': 'DEVICE', 'description': '3D imaging and wound and per-wound skin characteristics will be conducted initially, at dressing changes and at end of treatment/study.', 'armGroupLabels': ['Veraflo™ Cleanse Choice Complete™ Dressing Use with Assessments']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55144', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': '3M', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solventum US LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': '3M', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}