Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04583605
Status:
UNKNOWN
Last Update Posted:
2020-10-12
First Post:
2020-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Aim of This Study is to Demonstrat That Vacuum-assisted Closure Versus Conventional Wound Closure Enables to Diminish Local Complications After Lymph Node Dissection in Patients With Metastatic Skin Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D008207', 'term': 'Lymphatic Metastasis'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2020-07-20', 'studyFirstSubmitQcDate': '2020-10-06', 'lastUpdatePostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Is there a visible scar disunion ?', 'timeFrame': 'between day 1 and day 7, between day 7 and day 30, between day 30 and first year end', 'description': "Yes if there is a scar opening, no if there isn't"}, {'measure': 'Is there lymphorrhoea from the scar ?', 'timeFrame': 'between day 1 and day 7, between day 7 and day 30, between day 30 and first year end', 'description': "Yes if there is lymph coming from the the scar, no if there isn't."}], 'secondaryOutcomes': [{'measure': 'Are there lymphocele punctures ?', 'timeFrame': 'between day 1 and day 7, between day 7 and day 30, between day 30 and first year end', 'description': "Yes if there is any lymphocele puncture, no if there isn't"}, {'measure': 'Is there any lymphoedema ?', 'timeFrame': 'between day 1 and day 7, between day 7 and day 30, between day 30 and first year end', 'description': "Yes if there is arm or leg lymphoedema, no if there isn't"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vacuum assisted closure', 'PRENEVA', 'lymph node dissection'], 'conditions': ['Melanoma', 'Skin Cancer', 'Epidermoid Carcinoma', 'Neuroendocrine Carcinoma', 'Lymph Node Metastases']}, 'referencesModule': {'references': [{'pmid': '36283927', 'type': 'DERIVED', 'citation': 'Poirier A, Albuisson E, Bihain F, Granel-Brocard F, Perez M. Does Preventive Negative Pressure Wound Therapy (NPWT) reduce local complications following Lymph Node Dissection (LND) in the management of metastatic skin tumors? J Plast Reconstr Aesthet Surg. 2022 Dec;75(12):4403-4409. doi: 10.1016/j.bjps.2022.08.054. Epub 2022 Aug 24.'}]}, 'descriptionModule': {'briefSummary': 'In this study, we compared a negative pressure wound therapy, versus a conventional dressing in order to evaluate the most efficient wound therapy closure after axillary and inguinal lymph nodes dissections in the management of metastatic skin tumors. A vacuum assisted closure therapy should prevent these comorbidities.', 'detailedDescription': 'Lymphorrhoea, lymphedema and lymphocyte are significant and common complications after axillary and inguinal lymph nodes dissections. A vacuum assisted closure therapy should prevent these comorbidities. In this study, we compared PREVENA, a negative pressure wound therapy, versus conventional dressings. We evaluated the wound complications at the seventh day, the thirtieth day and at this end of the first year after surgery. It is a retrospective study of about ninety lymph nodes dissections among with there were seventy times the use of a negative pressure wound therapy, PREVENA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'major patient affected by a metastatic skin tumors', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* major patient affected by a metastatic skin tumors\n* the primitive skin tumor is either a mélanoma, either squamous cell carcinoma , or a neuroendocrine tumor\n\nExclusion Criteria:\n\n* lymph node dissection resumption'}, 'identificationModule': {'nctId': 'NCT04583605', 'briefTitle': 'The Aim of This Study is to Demonstrat That Vacuum-assisted Closure Versus Conventional Wound Closure Enables to Diminish Local Complications After Lymph Node Dissection in Patients With Metastatic Skin Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Does PREVENA Vacuum-assisted Closure Reduce Lymphorrhoea Compared to Conventional Wound Closure After Axillary and Inguinal Lymph Node Dissection in the Management of Metastatic Cutaneous Skin Tumors ?', 'orgStudyIdInfo': {'id': 'MR004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PREVENA', 'description': 'A vacuum wound closure therapy like PREVENA is applied after axillary or inguinal lymph node dissection in the management of metastatic skin tumors', 'interventionNames': ['Device: PREVENA']}, {'label': 'NON PREVENA', 'description': 'A conventional wound closure is applied after axillary or inguinal lymph node dissection in the management of metastatic skin tumors'}], 'interventions': [{'name': 'PREVENA', 'type': 'DEVICE', 'description': 'A negative pressure wound closure therapy is used after lymph node dissection', 'armGroupLabels': ['PREVENA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'CHRU', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Manuela PEREZ', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Visceral Surgery Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}