Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-31 @ 4:51 AM
Study NCT ID:
NCT00494793
Status:
COMPLETED
Last Update Posted:
2017-12-29
First Post:
2007-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059325', 'term': 'Intra-Abdominal Hypertension'}, {'id': 'D000069290', 'term': 'Incisional Hernia'}], 'ancestors': [{'id': 'D003161', 'term': 'Compartment Syndromes'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2015-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-28', 'studyFirstSubmitDate': '2007-06-29', 'studyFirstSubmitQcDate': '2007-06-29', 'lastUpdatePostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary fascial closure rate', 'timeFrame': '2 months', 'description': 'Primary fascial closure rate with the technique'}], 'secondaryOutcomes': [{'measure': 'Factors associated with failure of fascial closure and in-hospital mortality, abdominal pressure, duration of treatment with open abdomen, frequency of incisional hernia development', 'timeFrame': '5 years', 'description': 'Early, intermediate and late outcomes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Open abdomen', 'Fascial closure', 'Vacuum assisted wound closure', 'Mesh', 'Abdominal compartment syndrome', 'Intraabdominal pressure', 'Incisional hernia'], 'conditions': ['Open Abdomen', 'Fascial Closure']}, 'referencesModule': {'references': [{'pmid': '23703638', 'type': 'DERIVED', 'citation': 'Bjarnason T, Montgomery A, Ekberg O, Acosta S, Svensson M, Wanhainen A, Bjorck M, Petersson U. One-year follow-up after open abdomen therapy with vacuum-assisted wound closure and mesh-mediated fascial traction. World J Surg. 2013 Sep;37(9):2031-8. doi: 10.1007/s00268-013-2082-x.'}, {'pmid': '23465456', 'type': 'DERIVED', 'citation': 'Sorelius K, Wanhainen A, Acosta S, Svensson M, Djavani-Gidlund K, Bjorck M. Open abdomen treatment after aortic aneurysm repair with vacuum-assisted wound closure and mesh-mediated fascial traction. Eur J Vasc Endovasc Surg. 2013 Jun;45(6):588-94. doi: 10.1016/j.ejvs.2013.01.041. Epub 2013 Mar 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this multicenter trial is to prospectively evaluate a novel combination of vacuum assisted wound closure (VAWC) and mesh mediated fascial traction for closure of open abdomens.', 'detailedDescription': 'Open abdomen treatment often results in difficulties in closing the abdomen. Highest closure rates are seen with the vacuum assisted wound closure (VAWC) technique. Failures with this technique is occasionally experienced, especially in cases with severe visceral swelling needing longer treatment periods with open abdomen. A novel combination of vacuum assisted wound closure and mesh mediated fascial traction for managing the open abdomen was therefore developed and initially tested in a small pilot-like study with encouraging results with late primary closure of the abdomens in all seven patients.\n\nIn this multicenter study we prospectively evaluate the technique.\n\nInclusion criteria:\n\nAll patients treated with open abdomen at the 4 participating hospitals are registered, and only those patients who have commenced therapy with VAWC and mesh mediated fascial traction will be included in the study in an intention to treat model.\n\nExclusion criteria:\n\nTreatment of open abdomen with other techniques.\n\nMethod:\n\n* The first period of 2-5 days only the abdominal VAWC dressing is applied.\n* On day 3-10 a polypropylene mesh is sutured to the fascial edges, between the two layers of the VAWC system, and tightened.\n* The VAWC dressing is changed and the mesh tightened every 2-3 days, resulting in gradual approximation of the fascial edges.\n* Finally the mesh is removed and the fascia is closed.\n* At closure the wound to suture length is registered.\n\nPrimary endpoint:\n\nFrequency of primary fascial closure.\n\nSecondary endpoints:\n\n* study of factors associated with failure of fascial closure and in-hospital mortality,\n* abdominal pressure variation attributable to the use of the technique,\n* duration of treatment with open abdomen,\n* frequency of incisional hernia after one and five years.\n\nDuration of the study:\n\n3-5 years. Enrollment of open abdomen cases.\n\nFollow-up schedule for patients:\n\n* Clinical evaluation at 1 and 5 years.\n* CT-examination at 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* open abdomen patients with midline incisions, where vacuum assisted wound closure system and mesh mediated fascial traction is applicable\n\nExclusion Criteria:\n\n* open abdomen patients treated otherwise'}, 'identificationModule': {'nctId': 'NCT00494793', 'briefTitle': 'Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction', 'organization': {'class': 'OTHER', 'fullName': 'Skane University Hospital'}, 'officialTitle': 'Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction - Prospective Study of a Novel Technique for Open Abdomen Closure', 'orgStudyIdInfo': {'id': 'EPNLund 564/2005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'VAWC and mesh mediated fascial traction', 'description': 'This is a study aiming to evaluate one technique for temporary abdominal closure for open abdomen therapy in all patients applicable according to the inclusion criteria', 'interventionNames': ['Procedure: VAWC and mesh mediated fascial traction']}], 'interventions': [{'name': 'VAWC and mesh mediated fascial traction', 'type': 'PROCEDURE', 'description': 'The first period of 2-5 days only the abdominal VAWC dressing is applied. On day 3-10 a polypropylene mesh is sutured to the fascial edges, between the two layers of the VAWC system, and tightened.\n\nThe VAWC dressing is changed and the mesh tightened every 2-3 days, resulting in gradual approximation of the fascial edges.\n\nFinally the mesh is removed and the fascia is closed', 'armGroupLabels': ['VAWC and mesh mediated fascial traction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '791 82', 'city': 'Falun', 'country': 'Sweden', 'facility': 'Department of Surgery, Falu Hospital', 'geoPoint': {'lat': 60.60357, 'lon': 15.62597}}, {'zip': '801 87', 'city': 'Gävle', 'country': 'Sweden', 'facility': 'Department of Surgery, Gävle Hospital', 'geoPoint': {'lat': 60.67452, 'lon': 17.14174}}, {'zip': '205 02', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Department of Surgery, Malmö University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '205 02', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Department of Vascular Surgery, Malmö University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '751 85', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Department of Surgery, Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Ulf Petersson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery, Malmö University Hospital, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Skane University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uppsala University Hospital', 'class': 'OTHER'}, {'name': 'Gävle Hospital', 'class': 'OTHER'}, {'name': 'Falu Hospital', 'class': 'OTHER'}, {'name': 'KCI Europe Holding B.V.', 'class': 'INDUSTRY'}, {'name': 'The Swedish Research Council', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Ass prof', 'investigatorFullName': 'Ulf Petersson', 'investigatorAffiliation': 'Skane University Hospital'}}}}