Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

Recruiting now · Not applicable

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

In brief

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.

Key facts

Study ID

NCT05898074

Run by

Indiana University

People needed

30

Starts

2023-10-09

Expected to finish

2026-06-09

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Indiana University — Indianapolis, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

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