Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery
Recruiting
N/AInterventional Study
Skull Base NeoplasmsCerebrospinal Fluid LeakageNasal; Hypertrophy, Mucous Membrane (Septum)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Indiana University · Other
Who this trial is looking for
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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.
Trial Locations
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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 surgic…
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.
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