[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508258":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":49,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":25,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":25,"enrollmentInfo":67,"targetDuration":25,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":37,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Indiana University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PuraGel (RADA16) Hydrogel","ACTIVE_COMPARATOR","Participant will have PuraGel (RADA16) Hydrogel applied to the nasoseptal flap harvest site following endoscopic skull base surgery",[13],"Device: PuraGel (RADA16) Hydrogel",{"label":15,"type":10,"description":16,"interventionNames":17},"Non-absorbable Packing (Silastic Splint)","Participant will have a silastic splint (Non-Absorbable Packing) applied to the nasoseptal flap harvest site following endoscopic skull base surgery with no additional packing or agent",[18],"Device: Non-Absorbable Packing (Silastic Splint)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Non-Absorbable Packing (Silastic Splint)","Participant will have silastic splint applied to nasoseptal flap harvest site",[15],null,{"type":21,"name":9,"description":27,"armGroupLabels":28,"otherNames":25},"Participant will have PuraGel (RADA16) Hydrogel applied to the nasoseptal flap harvest site",[9],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Satyan Sreenath, MD","CONTACT","(317) 944-0457","ssreenat@iu.edu",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":25},"RECRUITING","Indianapolis","Indiana","46202","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-86.15804,39.76838,{"lat":47,"lon":46},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Satyan B. Sreenath","Assistant Professor, Department of Otolaryngology--Head and Neck Surgery",[54],{"name":55,"class":56},"3-D Matrix UK Ltd.","INDUSTRY","100508258","role-of-novel-rada16-hydrogel-in-endoscopic-skull-base-surgery-100508258",false,"NCT05898074","Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery","Novel Application of RADA16 Hydrogel in Reducing Sinonasal Morbidity After Endoscopic Skull Base Surgery","Inclusion Criteria:\n\n* Patient is 18 years of age or older\n* Patient is undergoing endoscopic endonasal approach for the management of a skull base tumor or cerebrospinal fluid leak. Nasoseptal Flap must be harvested.\n* Patient is undergoing surgery via bi-nostril approach requiring bilateral surgical dissection of the nasal cavity in approach to the skull base\n\nExclusion Criteria:\n\n* Patient has evidence of radiographic baseline sinus disease consistent with acute or chronic rhinosinusitis (including nasal polyposis, prior septal perforation) on pre-operative CT sinus\n* Patient has had prior sinonasal surgery or has undergone sinonasal radiation treatment\n* Patient has a known coagulation disorder or immune deficiency.",true,"ALL","18 Years",{"count":68,"type":69},30,"ESTIMATED","INTERVENTIONAL",[72],"NA","The purpose of this study is to specifically evaluate the effectiveness of PuraGel, a RADA16 polypeptide hydrogel, in expediting post-operative healing and re-mucosalization of the nasoseptal flap harvest site during endoscopic skull base surgery and the impact on patient and sinonasal morbidity.",[75,76,77],"Skull Base Neoplasms","Cerebrospinal Fluid Leakage","Nasal; Hypertrophy, Mucous Membrane (Septum)",[79,80,81,82],"Nasoseptal Flap Harvest","Sinonasal Morbidity","Extracellular Matrix","Endoscopic Skull Base Surgery","2026-04-06",{"date":85,"type":86},"2026-04-09","ACTUAL",{"date":88,"type":86},"2023-10-09",{"date":90,"type":69},"2026-06-09",{"name":5,"class":6},1]