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Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

RECRUITINGN/ASponsored by Indiana University
Actively Recruiting
PhaseN/A
SponsorIndiana University
Started2023-10-09
Est. completion2025-10-09
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions4

CancerCerebrospinal Fluid LeakageNasal; Hypertrophy, Mucous Membrane (Septum)Skull Base Neoplasms

Locations1 site

Indiana University
Indianapolis, Indiana, 46202

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