[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635854":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":27,"centralContacts":31,"locations":36,"responsibleParty":50,"collaborators":24,"id":53,"slug":24,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":24,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":24,"enrollmentInfo":61,"targetDuration":24,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":77,"whyStopped":24,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Closure (Control)","ACTIVE_COMPARATOR","* Standard RFFF harvest\n* Split-thickness skin graft (STSG) donor-site closure",[13],"Procedure: Standard Closure (Control)",{"label":15,"type":16,"description":17,"interventionNames":18},"Avive+ Intervention","EXPERIMENTAL","* Standard RFFF harvest\n* Placement of Avive+ Soft Tissue Matrix over the superficial radial nerve\n* STSG donor-site closure",[19],"Procedure: Avive+ Intervention",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"PROCEDURE",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":26,"otherNames":24},[15],[28],{"name":29,"affiliation":5,"role":30},"John M Le, MD, DDS","PRINCIPAL_INVESTIGATOR",[32],{"name":29,"role":33,"phone":34,"phoneExt":24,"email":35},"CONTACT","205-975-6356","jle@uabmc.edu",[37],{"facility":5,"status":24,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Birmingham","Alabama","35294","United States",{"type":43,"coordinates":44},"Point",[45,46],-86.80249,33.52066,{"lat":46,"lon":45},[49],{"name":29,"role":33,"phone":34,"phoneExt":24,"email":24},{"type":30,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"John M Le","Assistant Professor","100635854",false,"NCT07558096","Evaluating Avive+ Soft Tissue Matrix for Prevention of Superficial Radial Nerve Morbidity Following Radial Forearm Free Flap Harvest","A Randomized Controlled Pilot Study Evaluating Avive+ Soft Tissue Matrix for Prevention of Superficial Radial Nerve Morbidity Following Radial Forearm Free Flap Harvest","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Undergoing RFFF for head and neck reconstruction\n* Treated at University of Alabama at Birmingham\n* Able to provide informed consent\n* Willing to comply with follow-up\n\nExclusion Criteria:\n\n* Reconstruction using a non-RFFF free flap\n* Pre-existing ipsilateral radial nerve neuropathy\n* Prior ipsilateral forearm surgery affecting nerve anatomy\n* Active donor-site infection\n* Severe peripheral vascular disease\n* Inability to complete follow-up","ALL","18 Years",{"count":62,"type":63},80,"ESTIMATED","INTERVENTIONAL",[66],"NA","Radial forearm free flap (RFFF) reconstruction is commonly used for head and neck defects but is associated with donor-site morbidity, including neuropathic pain and sensory disturbance. This randomized controlled pilot study evaluates whether placement of a soft tissue matrix over the superficial radial nerve at the donor site reduces neuropathic pain and improves sensory outcomes compared to standard closure alone.",[69],"Head and Neck Cancer (H&N)",[71,72,73,74,75,76],"Head and Neck Cancer","Radial forearm free flap","Neuropathic pain","Superficial radial nerve","Donor site morbidity","Soft tissue matrix","NOT_YET_RECRUITING","2026-05-04",{"date":80,"type":81},"2026-05-08","ACTUAL",{"date":83,"type":63},"2026-07",{"date":85,"type":63},"2029-12",{"name":5,"class":6},1]