Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT06080958
Status:
COMPLETED
Last Update Posted:
2024-07-23
First Post:
2023-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Negative Pressure Wound Therapy in Flap Enhancement: Clinical Evaluation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Negative pressure wound therapy (vacuum-assisted wound closure) for postoperative flap care'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2023-10-08', 'studyFirstSubmitQcDate': '2023-10-08', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with primary healing', 'timeFrame': '2 weeks', 'description': 'Healing by epithelization without the need for secondary intervention'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with flap Edema', 'timeFrame': '1 week', 'description': 'flap edema clinical \\& radiological assessment'}, {'measure': 'Number of Participants with flap Congestion', 'timeFrame': '1 week', 'description': 'flap congestion clinical assessment'}, {'measure': 'Number of Participants with flap Ischemia', 'timeFrame': '1 week', 'description': 'flap ischemia clinical assessment'}, {'measure': 'Number of Participants with flap infection', 'timeFrame': '2 weeks', 'description': 'surgical site infection'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Surgical Flap', 'Negative-Pressure Dressings']}, 'referencesModule': {'references': [{'pmid': '40123035', 'type': 'DERIVED', 'citation': 'Elbanna OH, Eldine AS, Sayed AM, Mousa AK. The efficacy and safety of different negative-pressure wound therapy gradients on flaps outcomes. Updates Surg. 2025 Dec;77(8):2643-2651. doi: 10.1007/s13304-025-02156-7. Epub 2025 Mar 23.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to compare the clinical outcomes of using NPWT dressing versus conventional dressing in improving flaps outcome', 'detailedDescription': 'The cases will be divided into 3 major study groups:\n\n1st group will be managed with high negative pressure wound therapy The 2nd group will be managed with low negative pressure wound therapy The 3rd group will be managed with conventional dressing'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Adult patients skin and soft tissue defects that need flap coverage\n\nExclusion Criteria:\n\n* associated severe regional injuries uncontrolled comorbidities'}, 'identificationModule': {'nctId': 'NCT06080958', 'briefTitle': 'The Negative Pressure Wound Therapy in Flap Enhancement: Clinical Evaluation Study', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'Negative Pressure Wound Therapy in Flap Enhancement', 'orgStudyIdInfo': {'id': 'Aswan University Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High negative pressure group', 'description': 'A high negative pressure amplitude, (75- 125 mmHg) on continuous mode, is applied over the flaps', 'interventionNames': ['Device: NPWT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low negative pressure group', 'description': 'A low negative pressure amplitude, (50- \\<75 mmHg) on intermittent mode, is applied over the flaps', 'interventionNames': ['Device: NPWT']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Conventional dressing is applied over the flaps', 'interventionNames': ['Other: Conventional dressing']}], 'interventions': [{'name': 'NPWT', 'type': 'DEVICE', 'otherNames': ['VAC'], 'description': 'the NPWT dressing applied to fasciocutaneous flap', 'armGroupLabels': ['High negative pressure group', 'Low negative pressure group']}, {'name': 'Conventional dressing', 'type': 'OTHER', 'description': 'Conventional dressing ( topical care ) applied to fasciocutaneous flap', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81511', 'city': 'Aswān', 'country': 'Egypt', 'facility': 'Aswan University Hospital', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Ahmed Salah Eldin', 'investigatorAffiliation': 'Aswan University Hospital'}}}}