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โ† Trials
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Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

RecruitingNAAges 18 Years - anyAllIndiana University
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • Non-Absorbable Packing (Silastic Splint)
  • PuraGel (RADA16) Hydrogel
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Where

1 site
Indiana University
Indianapolis, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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