[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100462119":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":23,"collaborators":27,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":11,"eligibilityCriteria":37,"healthyVolunteers":38,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":11,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":11,"overallStatus":53,"whyStopped":11,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":11},{"fullName":5,"class":6},"Baylor College of Medicine","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":11},"Standard treatment, no intervention","NO_INTERVENTION",null,{"label":13,"type":14,"description":11,"interventionNames":15},"Standard treatment, plus ActiveMatrix","EXPERIMENTAL",[16],"Drug: ActiveMatrix",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"DRUG","ActiveMatrix","All patients will receive weight based prophylactic antibiotics i.e. Ancef, vancomycin, or clindamycin. Drains will be used in fusion cases only. Intrawound vancomycin will be used for all instrumented cases.No negative pressure devices will be used. Anatomic layers will be closed in similar, standard fashion for all cases. For those randomized to the treatment group, the ActiveMatrix product will be administered on top of the dura mater and again on the closed fascia. Those in the control group, will forgo this step.",[13],{"type":24,"investigatorFullName":25,"investigatorTitle":26,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Alfonso Fuentes, MD","Assistant Professor Neurosurgery BCM",[28],{"name":29,"class":30},"Skye Biologics Holdings, LLC","INDUSTRY","100462119","phase-4-efficacy-of-activematrix-on-spinal-ssi-rate-100462119",false,"NCT05297513","Efficacy of ActiveMatrix on Spinal SSI Rate","Efficacy of ActiveMatrix on Spinal Surgical Site Infection (SSI) Reduction: A Single-blinded Randomized Controlled Trial","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, ≥ 18 years of age to 100 years of age\n4. Have a clinical diagnosis of thoracic and or lumbosacral spinal disease indicated for decompression and\u002For fusion\n5. Have no contraindications or allergies to the treatment administered\n\nExclusion Criteria:\n\n1. Subject is involved with a worker's compensation, personal injury, or other legal matters related to their health\n2. Subject does not provide full consent\n3. Known history of allergy to allografts\n4. Pregnancy or lactation\n5. Minimally invasive spinal surgery\n6. Non-fusion instrumented cases requiring drains\n\nThere is no intended distribution or restriction of subjects by racial and ethnic origin. No vulnerable subjects are included in this protocol.",true,"ALL","18 Years","100 Years",{"count":43,"type":44},275,"ESTIMATED","INTERVENTIONAL",[47],"PHASE4","This clinical trial seeks to provide high level of evidence on the efficacy of ActiveMatrix primarily on spinal surgical site infection rate.",[50,51,52],"Spinal Stenosis Lumbar","Surgical Site Infection","Back Pain Lower Back Chronic","NOT_YET_RECRUITING","2022-03-30",{"date":56,"type":57},"2022-04-07","ACTUAL",{"date":59,"type":44},"2022-07",{"date":61,"type":44},"2026-07",{"name":5,"class":6}]