Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-28 @ 6:19 AM
Study NCT ID:
NCT02892435
Status:
UNKNOWN
Last Update Posted:
2016-09-08
First Post:
2015-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevena™ Incision Management System vs Conventional Management for Wound Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-01', 'studyFirstSubmitDate': '2015-05-19', 'studyFirstSubmitQcDate': '2016-09-01', 'lastUpdatePostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Site Infection (SSI) reduction', 'timeFrame': '7 months', 'description': 'quantify SSI decrease after incisional negative pressure wound therapy'}], 'secondaryOutcomes': [{'measure': 'Surgical Site Infection (SSI) and risk factors as diabetis, obesity and cancer', 'timeFrame': '2 years', 'description': 'check connection between wound complications and risk factors and showing if Incisional Negative Pressure Wound Therapy (INPWT) could reduce effects of these risk factors'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Wound Healing', 'Prevena', 'Dirty Abdominal Surgery', 'Contaminated Abdominal Surgery', 'Emergency Abdominal Surgery', 'Negative-Pressure Wound Therapy']}, 'descriptionModule': {'briefSummary': 'Comparison in abdominal wound healing after contaminated or dirty surgery with incisional negative pressure wound therapy versus standard dressing.', 'detailedDescription': 'All patients submitted to contaminated or dirty abdominal surgery have more risk of surgical site infections. The investigators intend to randomize this kind of patients and comparison wound healing after dressed with incisional negative pressure wound therapy or standard dressing.\n\nIn the study group INPWT (Prevena) is positioned immediately next surgery and dressed for six days. Every patients will be medicate in sixth, ninth, fifteenth and thirtieth day after surgery and will be valued wound healing with a scale score.\n\nMoreover for each patient it will be assessed risk developing wound complications through possum score and comorbidities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* abdominal surgery\n* open surgery\n* contaminated or dirty surgery\n\nExclusion Criteria:\n\n* not abdominal surgery\n* mininvasive surgery\n* clean surgery'}, 'identificationModule': {'nctId': 'NCT02892435', 'briefTitle': 'Prevena™ Incision Management System vs Conventional Management for Wound Healing', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Misericordia e Dolce'}, 'officialTitle': 'Wound Healing After Dirty/Contaminated Emergency Abdominal Surgery: Prevena™ Incision Management System vs Conventional Management', 'orgStudyIdInfo': {'id': '012/2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prevena arm', 'description': 'patients underwent to contaminated/dirty surgery who positioned incisional negative pressure wound therapy and kept for six days', 'interventionNames': ['Device: incisional negative pressure wound therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control arm', 'description': 'patients underwent to contaminated/dirty surgery who positioned conventional dressing', 'interventionNames': ['Device: conventional dressing']}], 'interventions': [{'name': 'incisional negative pressure wound therapy', 'type': 'DEVICE', 'otherNames': ['Prevena - KCI'], 'description': 'positioning incisional negative pressure therapy over closed wound.', 'armGroupLabels': ['Prevena arm']}, {'name': 'conventional dressing', 'type': 'DEVICE', 'description': 'positioning conventional dressing', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Prato', 'state': 'Po', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Feroci, MD', 'role': 'CONTACT', 'email': 'fferoci@yahoo.it', 'phone': '+393398382381'}, {'name': 'Luca Romoli, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andrea Vannucchi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alessia Garzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tiku Zalla, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Misericordia e Dolce Hospital', 'geoPoint': {'lat': 43.8805, 'lon': 11.09699}}], 'centralContacts': [{'name': 'Alessia Garzi, MD', 'role': 'CONTACT', 'email': 'alessia.garzi@gmail.com', 'phone': '0574804612', 'phoneExt': '+39'}, {'name': 'Marco Scatizzi, MD', 'role': 'CONTACT', 'email': 'fferoci@usl4.toscana.it', 'phone': '0574804612', 'phoneExt': '+39'}], 'overallOfficials': [{'name': 'Francesco Feroci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Santo Stefano Prato'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Misericordia e Dolce', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, general surgery department', 'investigatorFullName': 'Marco Scatizzi', 'investigatorAffiliation': 'Ospedale Misericordia e Dolce'}}}}