Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-02-25 @ 6:29 PM
Study NCT ID:
NCT05494450
Status:
TERMINATED
Last Update Posted:
2023-04-06
First Post:
2022-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open, Non-comparative, Multicenter Investigation to Evaluate the Safety and Performance of Exufiber Ag+, a Gelling Fiber Silver Dressing, When Used in Medium to High Exuding Chronic Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}, {'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D014647', 'term': 'Varicose Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D014648', 'term': 'Varicose Veins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'whyStopped': 'Sponsor decision secondary to data collection', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-04', 'studyFirstSubmitDate': '2022-08-08', 'studyFirstSubmitQcDate': '2022-08-08', 'lastUpdatePostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluate the safety and performance of Exufiber Ag+ in medium to high exuding chronic wounds', 'timeFrame': '28 Days', 'description': 'open, non-comparative, multicenter investigation'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pressure Ulcer', 'Diabetic Foot Ulcer', 'Venous Leg Ulcer']}, 'descriptionModule': {'briefSummary': 'An open, non-comparative, multicenter investigation to evaluate the safety and performance of Exufiber Ag+, a gelling fiber silver dressing, when used in medium to high exuding chronic wounds', 'detailedDescription': 'The overall objective of this post market clinical follow-up (PMCF) investigation is to confirm performance and safety of the Exufiber Ag+ dressing in medium to high exuding chronic wounds, with Mepilex Border Flex as the secondary dressing, when used in accordance with the Instructions for Use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed Informed Consent Form\n2. Patient aged ≥18 years old\n3. Patient with moderate to high exuding chronic wound (PU (stage II-IV), VLU or DFU)\n4. Patient with target wound that is a shallow to deep wound or cavity\n5. Patient with target wound that is ≥ 4 weeks in age\n6. Patient with target wound that is ≥ 8 cm2\n\nExclusion Criteria:\n\n1. Patient is contraindicated for the dressing according to product labeling\n2. Known allergy/hypersensitivity to any of the components of the investigation products\n3. Pregnancy/lactating female\n4. Patient with spreading soft tissue infection/cellulitis in the wound (as judged by the Investigator)\n5. Patient with known immunodeficiency\n6. Patient taking systemic antibiotics\n7. Patient with the target wound located on an infected limb and/or interfered by minimal blood flow in the opinion of the Investigator.\n8. Patient with the target wound with an unexplored enteric fistula\n9. Patient requiring treatment with oxidizing agents such as hypochlorite solutions or hydrogen peroxide\n10. Patient who, in the opinion of the Investigator, is not expected to comply with the investigation due to physical and/or mental conditions\n11. Patient who was previously enrolled in this investigation\n12. Patient participating in other investigations that would preclude the subject from participating in this investigation as judged by the Investigator\n13. Patient involved in the planning and conduct of the clinical investigation (applies to all Mölnlycke staff, investigational site staff, and third party vendor)'}, 'identificationModule': {'nctId': 'NCT05494450', 'briefTitle': 'An Open, Non-comparative, Multicenter Investigation to Evaluate the Safety and Performance of Exufiber Ag+, a Gelling Fiber Silver Dressing, When Used in Medium to High Exuding Chronic Wounds', 'organization': {'class': 'INDUSTRY', 'fullName': 'Molnlycke Health Care AB'}, 'officialTitle': 'An Open, Non-comparative, Multicenter Investigation to Evaluate the Safety and Performance of Exufiber Ag+, a Gelling Fiber Silver Dressing, When Used in Medium to High Exuding Chronic Wounds', 'orgStudyIdInfo': {'id': 'ExufiberAg+02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ExufiberAG+02', 'description': 'using ExufiberAG as the primary dressing on medium to high exuding chronic wounds.', 'interventionNames': ['Device: ExufiberAG+']}], 'interventions': [{'name': 'ExufiberAG+', 'type': 'DEVICE', 'description': 'confirm performance and safety of the Exufiber Ag+ dressing in medium to high exuding chronic wounds', 'armGroupLabels': ['ExufiberAG+02']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Center for Clinical Research', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '45342', 'city': 'Miamisburg', 'state': 'Ohio', 'country': 'United States', 'facility': 'Sycamore Wound Care and Hyperbaric Center', 'geoPoint': {'lat': 39.64284, 'lon': -84.28661}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Molnlycke Health Care AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}