Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-30 @ 8:58 AM
Study NCT ID:
NCT00789659
Status:
WITHDRAWN
Last Update Posted:
2017-02-10
First Post:
2008-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incisional Wound Vac in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054843', 'term': 'Negative-Pressure Wound Therapy'}], 'ancestors': [{'id': 'D004322', 'term': 'Drainage'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058106', 'term': 'Wound Closure Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI did not want to go forward with study at this time', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-08', 'studyFirstSubmitDate': '2008-11-12', 'studyFirstSubmitQcDate': '2008-11-12', 'lastUpdatePostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The comparative presence of drainage from the incisional wound treated with VAC therapy and the incisional wound treated with simple dry dressings at postoperative day 3.', 'timeFrame': '3 days'}], 'secondaryOutcomes': [{'measure': 'The presence or absence of additional procedures needed to gain control of any wound complications.', 'timeFrame': '3 days'}, {'measure': 'The amount of effluent contained in the V.A.C. canister.', 'timeFrame': '3 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fracture fixation, internal', 'Obesity', 'Pelvis', 'Negative pressure wound therapy', 'Vacuum-assisted closure'], 'conditions': ['Wound Infection', 'Postoperative Complication']}, 'referencesModule': {'references': [{'pmid': '17519604', 'type': 'BACKGROUND', 'citation': 'Baugh N, Zuelzer H, Meador J, Blankenship J. Wound wise: wounds in surgical patients who are obese. Am J Nurs. 2007 Jun;107(6):40-50; quiz 51. doi: 10.1097/01.NAJ.0000271848.07721.24.'}, {'pmid': '12805398', 'type': 'BACKGROUND', 'citation': 'Canturk Z, Canturk NZ, Cetinarslan B, Utkan NZ, Tarkun I. Nosocomial infections and obesity in surgical patients. Obes Res. 2003 Jun;11(6):769-75. doi: 10.1038/oby.2003.107.'}, {'pmid': '16790384', 'type': 'BACKGROUND', 'citation': 'Falagas ME, Kompoti M. Obesity and infection. Lancet Infect Dis. 2006 Jul;6(7):438-46. doi: 10.1016/S1473-3099(06)70523-0.'}, {'pmid': '15978153', 'type': 'BACKGROUND', 'citation': 'Fleischmann E, Kurz A, Niedermayr M, Schebesta K, Kimberger O, Sessler DI, Kabon B, Prager G. Tissue oxygenation in obese and non-obese patients during laparoscopy. Obes Surg. 2005 Jun-Jul;15(6):813-9. doi: 10.1381/0960892054222867.'}, {'pmid': '15995116', 'type': 'BACKGROUND', 'citation': 'Karunakar MA, Shah SN, Jerabek S. Body mass index as a predictor of complications after operative treatment of acetabular fractures. J Bone Joint Surg Am. 2005 Jul;87(7):1498-502. doi: 10.2106/JBJS.D.02258.'}, {'pmid': '17129369', 'type': 'BACKGROUND', 'citation': 'Rubin RH. Surgical wound infection: epidemiology, pathogenesis, diagnosis and management. BMC Infect Dis. 2006 Nov 27;6:171. doi: 10.1186/1471-2334-6-171.'}, {'pmid': '15492679', 'type': 'BACKGROUND', 'citation': 'Wilson JA, Clark JJ. Obesity: impediment to postsurgical wound healing. Adv Skin Wound Care. 2004 Oct;17(8):426-35. doi: 10.1097/00129334-200410000-00013.'}, {'pmid': '16799380', 'type': 'BACKGROUND', 'citation': 'Argenta LC, Morykwas MJ, Marks MW, DeFranzo AJ, Molnar JA, David LR. Vacuum-assisted closure: state of clinic art. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):127S-142S. doi: 10.1097/01.prs.0000222551.10793.51.'}, {'pmid': '16799379', 'type': 'BACKGROUND', 'citation': 'Morykwas MJ, Simpson J, Punger K, Argenta A, Kremers L, Argenta J. Vacuum-assisted closure: state of basic research and physiologic foundation. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):121S-126S. doi: 10.1097/01.prs.0000225450.12593.12.'}, {'pmid': '15943495', 'type': 'BACKGROUND', 'citation': 'Venturi ML, Attinger CE, Mesbahi AN, Hess CL, Graw KS. Mechanisms and clinical applications of the vacuum-assisted closure (VAC) Device: a review. Am J Clin Dermatol. 2005;6(3):185-94. doi: 10.2165/00128071-200506030-00005.'}, {'pmid': '17106382', 'type': 'BACKGROUND', 'citation': 'Gomoll AH, Lin A, Harris MB. Incisional vacuum-assisted closure therapy. J Orthop Trauma. 2006 Nov-Dec;20(10):705-9. doi: 10.1097/01.bot.0000211159.98239.d2.'}, {'pmid': '18827587', 'type': 'BACKGROUND', 'citation': 'Porter SE, Russell GV, Dews RC, Qin Z, Woodall J Jr, Graves ML. Complications of acetabular fracture surgery in morbidly obese patients. J Orthop Trauma. 2008 Oct;22(9):589-94. doi: 10.1097/BOT.0b013e318188d6c3.'}, {'pmid': '18373124', 'type': 'BACKGROUND', 'citation': 'Porter SE, Graves ML, Qin Z, Russell GV. Operative experience of pelvic fractures in the obese. Obes Surg. 2008 Jun;18(6):702-8. doi: 10.1007/s11695-007-9320-y. Epub 2008 Mar 29.'}]}, 'descriptionModule': {'briefSummary': 'It is the belief of the investigators that the current trends in complication rates associated with fixation of pelvic ring injuries and acetabular fractures in the obese are unacceptable. The overwhelming majority of these complications can be attributed to problems with surgical wound healing. The investigators feel that if a cost effective and easily performed intervention can be prospectively utilized in a specific at-risk orthopaedic trauma population in order to control a potentially devastating complication, then efforts in discovering such an intervention may prove valuable. It is our hypothesis that obese patients treated with V.A.C. therapy after standard closure of trauma-related, operative orthopaedic incisions will have fewer postoperative wound complications.', 'detailedDescription': "Obesity has been shown to be an independent risk factor for postoperative surgical infections in a variety of obesity related and non-obesity related surgeries. With the risk of an increasingly more obese society, complication rates that significantly differ based on patients' relative obesity may become increasingly unacceptable. The purpose of the proposed prospective study is to evaluate the role that vacuum assisted closure (VAC) may play in reducing these complication rates. Negative pressure or vacuum assisted closure was first introduced in 1997 as a way to control and potentially treat chronic wounds. Since that time, the indications have exploded to include a variety of chronic and acute wound healing problems. We have anecdotally been using VAC therapy (V.A.C.;KCI, San Antonio, Texas) in an effort to control the postoperative draining that is nearly ubiquitous in our morbidly obese orthopaedic trauma patients. The V.A.C. dressing is applied to the acute postoperative wound and maintained during the immediate postoperative period. Although a novel approach to the use of the V.A.C., this use has been previously reported in the orthopaedic literature as a case series. To our knowledge, there has not been a prospective study evaluating the efficacy of the immediate placement of a V.A.C. dressing on postoperative wound infection rates in the setting of the morbidly obese orthopaedic trauma patient. It is our hypothesis that obese patients treated with V.A.C. therapy after standard closure of trauma-related, operative orthopaedic incisions will have fewer postoperative wound complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between the ages of 18 - 64\n* Patients with a BMI greater than or equal to 30\n* Patients with acetabular, pelvic ring, or proximal femur fractures with a degree of displacement that would require an open reduction for treatment under normal circumstances\n\nExclusion Criteria:\n\n* Patients not within variables defined by the inclusion criteria\n* Abdominal or urological surgery during the same hospital admission\n* Ipsilateral soft tissue injuries that can be classified as internal degloving injuries'}, 'identificationModule': {'nctId': 'NCT00789659', 'briefTitle': 'Incisional Wound Vac in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Mississippi Medical Center'}, 'officialTitle': 'Incisional Wound Vac in Obese Patients', 'orgStudyIdInfo': {'id': '2008-0142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VAC dressing', 'description': 'The patients whose postoperative wound will be dressed with a negative pressure (V.A.C.) dressing.', 'interventionNames': ['Other: Negative pressure dressing']}], 'interventions': [{'name': 'Negative pressure dressing', 'type': 'OTHER', 'otherNames': ['V.A.C.'], 'description': 'A completely occlusive dressing that is attached to a device that allows a constant negative pressure of 125 mmHg to be generated.', 'armGroupLabels': ['VAC dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}], 'overallOfficials': [{'name': 'Matthew Graves, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Mississippi Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Mississippi Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Orthopaedic Trauma Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}