Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-30 @ 4:52 PM
Study NCT ID:
NCT00915967
Status:
COMPLETED
Last Update Posted:
2019-04-30
First Post:
2009-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prevention of Neurosurgical Wound Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014640', 'term': 'Vancomycin'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nsgclinicalresearch@ohsu.edu', 'phone': '503-494-4314', 'title': 'Director of Clinical Trials', 'organization': 'Oregon Health & Science University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'The study aimed to determine whether retrospectively observed decrease in infection rate could be attributed to the addition of local antibiotics A prospective, randomized, double-blind, placebo-controlled pilot study comparing standard antibiotic prophylaxis with addition of local intrawound injection of vancomycin or placebo, was designed.\n\nStudy Procedures were standard of care, risk was minimal', 'eventGroups': [{'id': 'EG000', 'title': 'Vancomycin', 'description': 'Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket.\n\nVancomycin: Subjects randomized to the vancomycin group will receive an injection (up to 10 mL) of 5 mg/mL vancomycin administered directly into the wound with a blunt needle following watertight fascial closure.', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 2, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Saline', 'description': 'Subjects in the saline group will receive a Saline injection directly into the wound pocket.\n\nPlacebo (Saline Solution): Subjects randomized to the saline group will receive an injection (up to 10 mL) of saline solution directly into the wound following watertight fascial closure.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 5, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Infection', 'notes': 'Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Infection That Requires Removal of the Neurosurgical Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vancomycin', 'description': 'Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket.\n\nVancomycin: Subjects randomized to the vancomycin group will receive an injection (up to 10 mL) of 5 mg/mL vancomycin administered directly into the wound with a blunt needle following watertight fascial closure.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Subjects in the saline group will receive a Saline injection directly into the wound pocket.\n\nPlacebo (Saline Solution): Subjects randomized to the saline group will receive an injection (up to 10 mL) of saline solution directly into the wound following watertight fascial closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Six months post-operation', 'description': 'The primary outcome was infection that required removal of the implanted device within 6 months of surgery. At our institution all patients with evidence of hardware infection have the entire stimulation/pump system removed. Subjects were either seen in clinic or reached by telephone more than 6 months after surgery and assessed for whether they had had infection requiring hardware removal or any superficial infection requiring additional post-operative antibiotics.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vancomycin', 'description': 'Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket.\n\nVancomycin: Subjects randomized to the vancomycin group will receive an injection (up to 10 mL) of 5 mg/mL vancomycin administered directly into the wound with a blunt needle following watertight fascial closure.'}, {'id': 'FG001', 'title': 'Saline', 'description': 'Subjects in the saline group will receive a Saline injection directly into the wound pocket.\n\nPlacebo (Saline Solution): Subjects randomized to the saline group will receive an injection (up to 10 mL) of saline solution directly into the wound following watertight fascial closure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '214 subjects signed consent. 198 subjects were enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vancomycin', 'description': 'Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket.\n\nVancomycin: Subjects randomized to the vancomycin group will receive an injection (up to 10 mL) of 5 mg/mL vancomycin administered directly into the wound with a blunt needle following watertight fascial closure.'}, {'id': 'BG001', 'title': 'Saline', 'description': 'Subjects in the saline group will receive a Saline injection directly into the wound pocket.\n\nPlacebo (Saline Solution): Subjects randomized to the saline group will receive an injection (up to 10 mL) of saline solution directly into the wound following watertight fascial closure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000', 'lowerLimit': '55', 'upperLimit': '71'}, {'value': '64', 'groupId': 'BG001', 'lowerLimit': '54', 'upperLimit': '74'}, {'value': '63.5', 'groupId': 'BG002', 'lowerLimit': '54', 'upperLimit': '74'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2014-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-08', 'studyFirstSubmitDate': '2009-06-05', 'resultsFirstSubmitDate': '2019-01-17', 'studyFirstSubmitQcDate': '2009-06-05', 'lastUpdatePostDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-08', 'studyFirstPostDateStruct': {'date': '2009-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Infection That Requires Removal of the Neurosurgical Device', 'timeFrame': 'Six months post-operation', 'description': 'The primary outcome was infection that required removal of the implanted device within 6 months of surgery. At our institution all patients with evidence of hardware infection have the entire stimulation/pump system removed. Subjects were either seen in clinic or reached by telephone more than 6 months after surgery and assessed for whether they had had infection requiring hardware removal or any superficial infection requiring additional post-operative antibiotics.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Infection', 'Vancomycin', 'Neurosurgery', 'Stimulator', 'Pump', 'Deep Brain Stimulation', 'Intrathecal Pump'], 'conditions': ['Surgical Wound Infections']}, 'referencesModule': {'references': [{'pmid': '19263587', 'type': 'BACKGROUND', 'citation': 'Miller JP, Acar F, Burchiel KJ. Significant reduction in stereotactic and functional neurosurgical hardware infection after local neomycin/polymyxin application. J Neurosurg. 2009 Feb;110(2):247-50. doi: 10.3171/2008.6.17605.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to determine whether injecting the antibiotic vancomycin directly into surgical wounds can decrease the rate of infection following implantation of neurosurgical devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* deep brain stimulators (DBS)\n* spinal cord stimulators (SCS)\n* motor cortex stimulators (MCS)\n* vagus nerve stimulators (VNS)\n* peripheral nerve stimulators (PNS)\n\nExclusion Criteria:\n\n* allergies to vancomycin\n* immunocompromise or taking immunosuppressant drugs\n* currently taking aminoglycoside antibiotics, such as amikacin, gentamicin, neomycin, streptomycin or tobramycin\n* diagnosed renal failure\n* currently undergoing chemotherapy\n* pregnancy\n* non-english speakers\n* unable to return for follow-up, or unable to be contacted by telephone'}, 'identificationModule': {'nctId': 'NCT00915967', 'acronym': 'POWI', 'briefTitle': 'Prevention of Neurosurgical Wound Infections', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Pilot Project: Prevention of Neurosurgical Wound Infections', 'orgStudyIdInfo': {'id': 'IRB_5170'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vancomycin', 'description': 'Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket.', 'interventionNames': ['Drug: Vancomycin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Subjects in the saline group will receive a Saline injection directly into the wound pocket.', 'interventionNames': ['Drug: Placebo (Saline Solution)']}], 'interventions': [{'name': 'Vancomycin', 'type': 'DRUG', 'description': 'Subjects randomized to the vancomycin group will receive an injection (up to 10 mL) of 5 mg/mL vancomycin administered directly into the wound with a blunt needle following watertight fascial closure.', 'armGroupLabels': ['Vancomycin']}, {'name': 'Placebo (Saline Solution)', 'type': 'DRUG', 'description': 'Subjects randomized to the saline group will receive an injection (up to 10 mL) of saline solution directly into the wound following watertight fascial closure.', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'University Hospital, Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Kim J Burchiel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurological Surgery, Oregon Health & Science University'}, {'name': 'Valerie C Anderson, PhD, MCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurological Surgery, Oregon Health & Science University'}, {'name': 'Stephen T Magill, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Medicine, Oregon Health & Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Kim J. Burchiel, MD / John Raaf Professor and Chairman, Department of Neurological Surgery', 'investigatorFullName': 'Kim J. Burchiel', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}