RecruitingNot ApplicableNCT05898074

Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

Novel Application of RADA16 Hydrogel in Reducing Sinonasal Morbidity After Endoscopic Skull Base Surgery

Sponsor

Indiana University

Enrollment

30 participants

Start Date

Oct 9, 2023

Study Type

INTERVENTIONAL

Conditions

Cerebrospinal Fluid Leakage Skull Base Neoplasms Nasal; Hypertrophy, Mucous Membrane (Septum)

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria3

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.

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