Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University

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

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Indiana University

Lead sponsor

3-D Matrix UK Ltd.

Collaborator