[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508258":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":48,"collaborators":52,"id":56,"slug":25,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":25,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":25,"enrollmentInfo":65,"targetDuration":25,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":37,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"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,"cosmosGeoPoint":42,"geoPoint":47,"contacts":25},"RECRUITING","Indianapolis","Indiana","46202","United States",{"type":43,"coordinates":44},"Point",[45,46],-86.15804,39.76838,{"lat":46,"lon":45},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Satyan B. Sreenath","Assistant Professor, Department of Otolaryngology--Head and Neck Surgery",[53],{"name":54,"class":55},"3-D Matrix UK Ltd.","INDUSTRY","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":66,"type":67},30,"ESTIMATED","INTERVENTIONAL",[70],"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.",[73,74,75],"Skull Base Neoplasms","Cerebrospinal Fluid Leakage","Nasal; Hypertrophy, Mucous Membrane (Septum)",[77,78,79,80],"Nasoseptal Flap Harvest","Sinonasal Morbidity","Extracellular Matrix","Endoscopic Skull Base Surgery","2026-04-06",{"date":83,"type":84},"2026-04-09","ACTUAL",{"date":86,"type":84},"2023-10-09",{"date":88,"type":67},"2026-06-09",{"name":5,"class":6},1]