About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Non-Absorbable Packing (Silastic Splint)
- PuraGel (RADA16) Hydrogel
Treatment groups
Sponsors and collaborators
Indiana University
Lead sponsor
3-D Matrix UK Ltd.
Collaborator