Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT05898074
Status
Recruiting
Apply to this trial

Conditions

  • Cerebrospinal Fluid Leakage
  • Nasal; Hypertrophy, Mucous Membrane (Septum)
  • Skull Base Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Non-Absorbable Packing (Silastic Splint) — DEVICE
    Participant will have silastic splint applied to nasoseptal flap harvest site
  • PuraGel (RADA16) Hydrogel — DEVICE
    Participant will have PuraGel (RADA16) Hydrogel applied to the nasoseptal flap harvest site

Study Details

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.

Key Dates

Start date
Oct 9, 2023
Status verified
Apr 2026
Primary completion
Jun 9, 2026
Completion
Jun 9, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Change in Modified Lund-Kennedy nasal endoscopy score [ Time Frame: 1 week, 4 weeks, and 12 weeks following surgery. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana UniversityIndianapolisIndiana46202-

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By research site
Indiana University· Indianapolis, IN

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