Actively Recruiting
Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery
Led by Indiana University · Updated on 2026-04-09
30
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
3
3-D Matrix UK Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age or older
- Patient is undergoing endoscopic endonasal approach for management of a skull base tumor or cerebrospinal fluid leak with nasoseptal flap harvest
- Surgery involves a bi-nostril approach requiring bilateral surgical dissection of the nasal cavity to the skull base
You will not qualify if you...
- Evidence of radiographic baseline sinus disease including acute or chronic rhinosinusitis, nasal polyposis, or prior septal perforation on pre-operative CT sinus
- Prior sinonasal surgery or sinonasal radiation treatment
- Known coagulation disorder or immune deficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
S
Satyan Sreenath, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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