Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-07-06 @ 2:02 AM
Study NCT ID:
NCT02953769
Status:
TERMINATED
Last Update Posted:
2019-08-01
First Post:
2016-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevena Incision Management System Wound Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006555', 'term': 'Hernia, Ventral'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Principal Investigator left the Hospital and did not transfer the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-30', 'studyFirstSubmitDate': '2016-11-01', 'studyFirstSubmitQcDate': '2016-11-02', 'lastUpdatePostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Objective for Wound Care Comparison', 'timeFrame': 'December 31, 2017', 'description': 'To quantify differences in the routine care of wound morbidity versus the use of Prevena™ by observing the healing process and obtaining quality of life by using the Carolinas Comfort Scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ventral Hernia']}, 'descriptionModule': {'briefSummary': 'Comparison of ventral hernia repair using standard wound care versus Prevena.', 'detailedDescription': 'Compare the outcomes for patients who have abdominal reconstruction for ventral hernia repair, regarding wound morbidity, post-operative pain and patient comfort to ambulation, with the use of Prevena™ to those patients who have ventral hernia repair to those who have standard wound care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Elective Ventral hernia repair', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 - 89\n2. Open ventral hernia repair with or abdominal wall reconstruction after midline or non-midline defects.\n3. Able to provide informed consent\n\nExclusion Criteria:\n\n1. Immunosuppresses patients\n2. Children 0 - 17'}, 'identificationModule': {'nctId': 'NCT02953769', 'briefTitle': 'Prevena Incision Management System Wound Care', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth'}, 'officialTitle': 'Use of Prevena Incision Management System in Wound Morbidity in Complex Ventral Hernia Patients. A Prospective Randomized Control Trial', 'orgStudyIdInfo': {'id': '951279'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm 1', 'description': 'Ventral hernia repair using standard wound care.'}, {'label': 'Arm 2', 'description': 'Ventral hernia repair, regarding wound morbidity, post-operative pain and patient comfort to ambulation, with the use of Prevena™'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34747', 'city': 'Celebration', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Celebration Health', 'geoPoint': {'lat': 28.32529, 'lon': -81.53313}}], 'overallOfficials': [{'name': 'Eduardo Parra Davila, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Physician'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth', 'class': 'OTHER'}, 'collaborators': [{'name': 'KCI USA, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}