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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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05898074). StuddyBuddy aggregates publicly available trial information.