Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT05883033
Status:
UNKNOWN
Last Update Posted:
2023-05-31
First Post:
2023-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VAC and Conventional Dressing in the Healing Process of Necrotizing Fasciitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019115', 'term': 'Fasciitis, Necrotizing'}], 'ancestors': [{'id': 'D005208', 'term': 'Fasciitis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-28', 'studyFirstSubmitDate': '2023-04-22', 'studyFirstSubmitQcDate': '2023-05-28', 'lastUpdatePostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital staying length', 'timeFrame': 'Baseline', 'description': 'the difference in hospital stay length between patients with necrotizing fasciitis who received conventional management versus those treated with vacuum-assisted closure. A systematic review showed a significant difference between the two methods'}], 'secondaryOutcomes': [{'measure': 'Required other stages of debridement', 'timeFrame': 'Baseline', 'description': 'Comparison in the other stages of debridement required in both methods'}, {'measure': 'Expected closure of the wound by secondary intention', 'timeFrame': 'Baseline', 'description': 'The difference in expected time required for closure of the wound by secondary intention between patients with necrotizing fasciitis who received conventional management versus those treated with vacuum-assisted closure.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Necrotizing Fascitis']}, 'referencesModule': {'references': [{'pmid': '36737764', 'type': 'BACKGROUND', 'citation': 'Zhang R, Zhang Y, Hou L, Yan C. Vacuum-assisted closure versus conventional dressing in necrotizing fasciitis: a systematic review and meta-analysis. J Orthop Surg Res. 2023 Feb 4;18(1):85. doi: 10.1186/s13018-023-03561-7.'}]}, 'descriptionModule': {'briefSummary': 'Find out the best management of Necrotizing Fasciitis after surgical debridement', 'detailedDescription': 'Necrotizing fasciitis is a life-threatening condition that can occur as a result of trauma or foreign bodies in surgical wounds as well as idiopathically. Necrotizing fasciitis is characterized by a progressive infection in fascial planes with necrosis of the subcutaneous tissue. Necrotizing fasciitis affects the extremities more frequently than central areas. Risk factors for necrotizing fasciitis include diabetes mellitus, trauma wound infections, decubitus ulcers, alcoholism, carcinoma, peripheral vascular disease, smoking, and intravenous drug abuse. A varieties of micro-organisms, including gram-positive group A streptococcus, haemolytic streptococci, and staphylococcus aureus; gram-negative Enterobacteriaceae, Escherichia coli, Klebsiella spp., and Proteus spp.; anaerobes including Peptostreptococcus, Clostridium, and Pacteroides; and fungi such as Candida and acid-fast bacteria have all been implicated in the pathogenesis of Necrotizing fasciitis.\n\nNecrotizing fasciitis is a surgical emergency for detoxification by debridement with good antibiotic coverage. It has mortality rate reaching 20-30% , this mortality rate is high and requires prompt diagnosis, antibiotic treatment and extensive necrosectomy up to intensive care units admission in some cases, the aim of our prospective analysis is to assess with a hypothesis-generating and exploratory purpose the possible role of VAC versus ordinary dressings in the wound therapy of Necrotizing Fasciitis in terms of expected time for wound closure and survival rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Immunocompromised patients such as; diabetic, HIV and leukaemia.\n\nAnd other chronic debilitating diseases.\n\nExclusion Criteria:\n\n* Necrotizing Fasciitis of Head and neck and upper limbs.'}, 'identificationModule': {'nctId': 'NCT05883033', 'briefTitle': 'VAC and Conventional Dressing in the Healing Process of Necrotizing Fasciitis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparative Study Between Vacuum Assisted Closure (VAC) and Conventional Dressing in the Healing Process of Necrotizing Fasciitis After Surgical Debridement.. Clinical and Laboratory Study.', 'orgStudyIdInfo': {'id': 'Necrotizing fasciitis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vacuum Assisted Closure device', 'description': 'Vacuum Assisted Closure device for healing enhancement', 'interventionNames': ['Device: VAC']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional dressing', 'description': 'Unprocessed Honey, malysia glycerine and betadine ointment', 'interventionNames': ['Device: VAC']}], 'interventions': [{'name': 'VAC', 'type': 'DEVICE', 'description': 'Vacuum Assisted Closure device', 'armGroupLabels': ['Conventional dressing', 'Vacuum Assisted Closure device']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Mario Saba, BMMS', 'role': 'CONTACT', 'email': 'mario_saba_417@yahoo.com', 'phone': '+201091196224'}, {'name': 'Abdullah Badawi, PhD', 'role': 'CONTACT', 'email': 'abdallah.mersal@med.au.edu.eg', 'phone': '+201001861127'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Dr', 'investigatorFullName': 'Mario Youhana Saba', 'investigatorAffiliation': 'Assiut University'}}}}