Novel Application of RADA16 Hydrogel in Reducing Sinonasal Morbidity After Endoscopic Skull Base Surgery
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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
Locations
United States
Indiana
Indiana University
RECRUITING
Indianapolis
Contact Information
Primary
Satyan Sreenath, MD
ssreenat@iu.edu
(317) 944-0457
Time Frame
Start Date: 2023-10-09
Estimated Completion Date: 2025-10-09
Participants
Target number of participants: 30
Treatments
Active_comparator: PuraGel (RADA16) Hydrogel
Participant will have PuraGel (RADA16) Hydrogel applied to the nasoseptal flap harvest site following endoscopic skull base surgery
Active_comparator: Non-absorbable Packing (Silastic Splint)
Participant will have a silastic splint (Non-Absorbable Packing) applied to the nasoseptal flap harvest site following endoscopic skull base surgery with no additional packing or agent
Related Therapeutic Areas
Sponsors
Collaborators: 3-D Matrix UK Ltd.
Leads: Indiana University