Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-30 @ 5:45 AM
Study NCT ID:
NCT00582361
Status:
COMPLETED
Last Update Posted:
2013-08-14
First Post:
2007-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vacuum Assisted Closure as a Treatment for Open Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005597', 'term': 'Fractures, Open'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Talyor.vlack@ortho.uab.edu', 'phone': '205-996-6781', 'title': 'Research Nurse Coordinator', 'organization': 'UAB'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'None Noted.'}}, 'adverseEventsModule': {'timeFrame': 'Through 12 months (date of surgery through 12 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Dressing Group (1, A)', 'description': 'Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vacuum Assisted Closure Group (2, B)', 'description': 'Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.', 'otherNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'seriousNumAffected': 4}], 'seriousEvents': [{'term': 'Nonunion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Required Flap Coverage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nonunion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Healing of Orthopaedic Trauma Open Fractures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Dressing Group (1, A)', 'description': 'Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.'}, {'id': 'OG001', 'title': 'Vacuum Assisted Closure Group (2, B)', 'description': 'Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '9'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '11'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from surgery to wound closure', 'description': 'Healing of the open wound following orthopaedic trauma open fracture surgery was measured in days. (The wound has healed adequately to permit closure)', 'unitOfMeasure': 'use days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Dressing Group (1, A)', 'description': 'Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.'}, {'id': 'OG001', 'title': 'Vacuum Assisted Closure Group (2, B)', 'description': 'Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'Number of acute, delayed and deep wound infections.', 'unitOfMeasure': 'Number of infections', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-07'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Dressing Group (1, A)', 'description': 'Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.'}, {'id': 'FG001', 'title': 'Vacuum Assisted Closure Group (2, B)', 'description': 'Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients admitted through the emergency department that met the criteria for the study were approached.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Dressing Group (1, A)', 'description': 'Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.'}, {'id': 'BG001', 'title': 'Vacuum Assisted Closure Group (2, B)', 'description': 'Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '16', 'groupId': 'BG000'}, {'value': '38', 'spread': '15', 'groupId': 'BG001'}, {'value': '41', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-05', 'studyFirstSubmitDate': '2007-12-20', 'resultsFirstSubmitDate': '2011-07-27', 'studyFirstSubmitQcDate': '2007-12-27', 'lastUpdatePostDateStruct': {'date': '2013-08-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-13', 'studyFirstPostDateStruct': {'date': '2007-12-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healing of Orthopaedic Trauma Open Fractures', 'timeFrame': 'from surgery to wound closure', 'description': 'Healing of the open wound following orthopaedic trauma open fracture surgery was measured in days. (The wound has healed adequately to permit closure)'}, {'measure': 'Infections', 'timeFrame': 'Up to 12 months', 'description': 'Number of acute, delayed and deep wound infections.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Open Fractures', 'Vacuum Assisted Closure (VAC) device', 'Irrigation and Debridement'], 'conditions': ['Orthopaedic Traumatic Open Fractures']}, 'referencesModule': {'references': [{'pmid': '16582806', 'type': 'BACKGROUND', 'citation': 'Parrett BM, Matros E, Pribaz JJ, Orgill DP. Lower extremity trauma: trends in the management of soft-tissue reconstruction of open tibia-fibula fractures. Plast Reconstr Surg. 2006 Apr;117(4):1315-22; discussion 1323-4. doi: 10.1097/01.prs.0000204959.18136.36.'}, {'pmid': '15168301', 'type': 'BACKGROUND', 'citation': 'Steiert AE, Partenheimer A, Schreiber T, Muehlberger T, Krettek C, Lahoda LU, Vogt PM. [The V.A.C. system (vacuum assisted closure) as bridging between primary osteosynthesis in conjunction with functional reconstructed of soft tissue--open fractures type 2 and type 3]. Zentralbl Chir. 2004 May;129 Suppl 1:S98-100. doi: 10.1055/s-2004-822658. German.'}]}, 'descriptionModule': {'briefSummary': 'This project is designed as a prospective, randomized, comparative study evaluating the use of a negative pressure vacuum device in treating traumatic wounds sustained associated with an open fracture.', 'detailedDescription': 'Soft tissue injury following an open fracture is a significant problem following surgical treatment of traumatic skeletal injuries. The soft tissue injury results from a combination of the initiating trauma and additional tissue injury during surgery. Current treatment includes open reduction and internal fixation versus external fixation, irrigation and debridement following admission, decreased activity (non weight bearing status on the injured extremity), maintaining the patient as an inpatient in the hospital, repeated irrigation and debridements (36-72 hours following the initial trauma) with concomitant wound culturing until which time it is determined that either delayed primary closure, or skin grafting with/without flap coverage should be attempted.\n\nAll patients in the study will be treated with the appropriate empiric antibiotic regimen until wound culture results justify modification for antibiotic sensitivity/resistance reasons. In general, barring patient allergy, the empiric antibiotic regimen will adhere to the Gustilo and Anderson classification as follows:\n\nGrade I : Ancef Grade II : Ancef and Gentamicin or Zosyn Grade III : Ancef, Gentamicin or Zosyn, and add a Penicillin for grade IIIB open fractures.\n\nAll wounds will be assessed initially at admission following the Gustilo and Anderson classification for open fractures. Subsequent wound assessments in the operating room will be graded according to the following descriptive scale:\n\nType A wound: Abundant granulation tissue, ready for closure. Type B Wound: Granulation tissue present but inadequate for closure, Wound is clinically clean appearing. Type C Wound: No granulation tissue, no gross purulence. Type D Wound: Gross purulence/infected wound, no granulation tissue.\n\nThe outcome variables consist of the intraoperative and postoperative adverse device effects recorded in the medical record and on the study data collection form, time to wound closure, intraoperative and postoperative complications recorded in medical record and on the study data collection form. Clinical photographs of the wounds will be taken with a digital camera at the time of admission to the study, and during each subsequent trip to the operating room (every 48-72 hours). We will also record the injury severity score for all multiple trauma patients recorded at the time of injury in the medical record and on the study data collection form, and soft tissue score according to Gustillo and Anderson for open injuries in the medical record and on the study data collection form. Baseline serum albumin and total lymphocyte counts will be taken on admission to evaluate baseline nutritional and immunologic status at the time of injury. All patients in the Intensive Care Units will have daily weights, fluid balances, and nutritional intake documented. Resuscitation data will also be recorded from the trauma room, including fluids, blood, and base deficit. The effects will be measured by clinical examination and will be augmented with culture data for any wounds that require surgical intervention.\n\nPatients who have an open fracture and who give informed consent to enter the study will be randomized into two groups. Group A will be patients treated with a return to the operating room approximately 48 hours following the initial trauma, and approximately every 48 hours thereafter, for irrigation and debridement and concomitant wound cultures (qualitative and quantitative) until which time the wound is judged by the surgeon to be ready for either delayed primary closure or flap/skin graft coverage. Group B will be patients treated with a VAC negative pressure device following the initial surgical irrigation and debridement. Group B patients will return to the operating room approximately 48 hours following the initial irrigation and debridement for VAC removal, wound cultures (qualitative and quantitative), repeat irrigation and debridement, and wound evaluation by the surgeon for possible delayed closure versus reapplication of the VAC device. Group B patients will also be returned to the operating room approximately every 48 hours thereafter for irrigation and debridement and concomitant wound cultures (qualitative and quantitative) until the wound is judged ready for coverage or closure by the surgeon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who has sustained an open fracture that requires surgical irrigation and debridement.\n* No gross clinical evidence of infection.\n\nExclusion Criteria:\n\n* A grossly infected open wound. Infection will be defined by clinical signs and symptoms of infection that include increasing drainage, increasing pain, purulent drainage, and increasing erythema. Any wounds that are thought to be infected will be cultured to confirm the diagnosis.\n* A surgical incision that can not be covered with VAC sponges and a water impermeable sheet (such as Ioban or Tegaderm) to achieve a closed vacuum environment over the wound.\n* Wounds associated with the surgical incision that are intentionally left open to heal with either a delayed primary closure or secondary granulation\n* Abnormal coagulation leading to an expanding hematoma that will require surgical debridement.\n* Pregnant women.\n* Inability or unwillingness to comply with protocol.\n* Patients or family members who are unable or unwilling to sign study informed consent.'}, 'identificationModule': {'nctId': 'NCT00582361', 'acronym': 'VAC-OF', 'briefTitle': 'Vacuum Assisted Closure as a Treatment for Open Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Vacuum Assisted Closure as a Treatment for Open Fractures', 'orgStudyIdInfo': {'id': 'F010316004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1, A', 'description': 'Group A patients will have a standard dressing applied following initial treatment of their open fracture.', 'interventionNames': ['Procedure: Standard Wound Dressing']}, {'type': 'EXPERIMENTAL', 'label': '2, B', 'description': 'Group B patients will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.', 'interventionNames': ['Device: VAC']}], 'interventions': [{'name': 'Standard Wound Dressing', 'type': 'PROCEDURE', 'description': 'Group A patients will have a standard dressing applied following initial treatment of their open fracture. They will return to the operating room approximately 48 hours following the initial trauma, and approximately every 48 hours thereafter, for irrigation and debridement and concomitant wound cultures (qualitative and quantitative) until such time as the wound is judged by the surgeon to be ready for either delayed primary closure or flap/skin graft coverage.', 'armGroupLabels': ['1, A']}, {'name': 'VAC', 'type': 'DEVICE', 'otherNames': ['Vacuum Assisted Closure (VAC)'], 'description': 'Group B patients will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture. They will return to the operating room approximately 48 hours following the initial trauma, and approximately every 48 hours thereafter, for irrigation and debridement and concomitant wound cultures (qualitative and quantitative) until such time as the wound is judged by the surgeon to be ready for either delayed primary closure or flap/skin graft coverage.', 'armGroupLabels': ['2, B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The University of Alabama at Birmingham, Orthopaedic Trauma', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Rena L Stewart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'KCI USA, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}