[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610247":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":51,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":19,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":19,"enrollmentInfo":66,"targetDuration":19,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":80,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of Michigan","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"STRATAFIX PDS and Monocryl suture","EXPERIMENTAL","All participants enrolled will have their scheduled surgery as planned with their wound closed using STRATAFIX.",[13],"Device: STRATAFIX PDS and Monocryl suture",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","STRATAFIX, suture employs a novel incorporation of barbed components to suture resulting in tension holding closure with long-lasting absorbable suture.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Michael Karsy, MD, PhD, MSc","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Karen Sagher","CONTACT","734-232-4843","kfrisch@med.umich.edu",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"University of Michigan Health Sparrow","RECRUITING","Lansing","Michigan","48912","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-84.55553,42.73253,{"lat":43,"lon":42},[46,47,48],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},{"name":22,"role":23,"phone":19,"phoneExt":19,"email":19},{"name":49,"role":50,"phone":19,"phoneExt":19,"email":19},"Nasser M Yaghi, MD","SUB_INVESTIGATOR",{"type":23,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Michael Karsy","Assistant Clinical Professor of Neurosurgery",[55],{"name":56,"class":57},"Johnson & Johnson","INDUSTRY","100610247","phase-4-evaluation-of-the-efficacy-of-stratafix-for-neurosurgical-cranial-and-spine-procedures-100610247",false,"NCT07225101","Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures","Inclusion Criteria:\n\n* Elective or emergent surgical approaches for cranial or spine neurosurgical approaches, requiring sutures for wound closure, requiring multilayer wound closure\n\nExclusion Criteria:\n\n* Patients with prior surgical wound dehiscence or infection\n* Patients with allergy to suture material","ALL","18 Years",{"count":67,"type":68},160,"ESTIMATED","INTERVENTIONAL",[71],"PHASE4","This research is studying a device already approved by the Food and Drug Administration (FDA) to treat wound closures. Researchers are studying a large group of people to continue to learn information about the safety of the STRATAFIX suture and how people's bodies react to using it over a long period of time. This research will provide additional information about using STRATAFIX sutures to close surgical wounds.",[74,75,76,77,78,79],"Wound Closure","Brain Tumor Adult","Spine","Neurovascular","Hemorrhagic Stroke, Intracerebral","Traumatic Brain Injury",[81,82,83,84,85,86,87,88,89],"Superficial surgical site infection","Suture material","Wound closure techniques","brain tumor","spine","spine trauma","neurosurgery","hemorrhagic stroke","traumatic brain injury","2025-11-03",{"date":92,"type":93},"2025-11-05","ACTUAL",{"date":95,"type":93},"2025-11-01",{"date":97,"type":68},"2026-12-31",{"name":5,"class":6},1]