← Back to all trials
Recruiting
NCT05898074
Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery
Conditions: Skull Base Neoplasms, Cerebrospinal Fluid Leakage, Nasal; Hypertrophy, Mucous Membrane (Septum)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 30
Sponsor: Indiana University
Location: Indiana University Indianapolis Indiana
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Patient is 18 years of age or older
* Patient is undergoing endoscopic endonasal approach for the management of a skull base tumor or cerebrospinal fluid leak. Nasoseptal Flap must be harvested.
* Patient is undergoing surgery via bi-nostril approach requiring bilateral surgical dissection of the nasal cavity in approach to the skull base
Exclusion Criteria:
* 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
* Patient has had prior sinonasal surgery or has undergone sinonasal radiation treatment
* Patient has a known coagulation disorder or immune deficiency.
Source: ClinicalTrials.gov (NCT05898074). StuddyBuddy aggregates publicly available trial information.