Recruiting

RADA16 Hydrogel

Sponsor:

Indiana University

Code:

NCT05898074

Conditions

Skull Base Neoplasms

Cerebrospinal Fluid Leakage

Nasal; Hypertrophy, Mucous Membrane (Septum)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Non-Absorbable Packing (Silastic Splint)

PuraGel (RADA16) Hydrogel

Study Details

Brief 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.

Conditions

Skull Base Neoplasms

Cerebrospinal Fluid Leakage

Nasal; Hypertrophy, Mucous Membrane (Septum)

Study ID

NCT05898074

Start date

Oct 9, 2023

Status verified date

Apr, 2026

Completion date

Feb 15, 2027

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Non-Absorbable Packing (Silastic Splint)

Participant will have silastic splint applied to nasoseptal flap harvest site

PuraGel (RADA16) Hydrogel

Participant will have PuraGel (RADA16) Hydrogel applied to the nasoseptal flap harvest site

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Satyan Sreenath, MD

(317) 944-0457ssreenat@iu.edu

Locations

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

More Information

Sponsor

Indiana University

Last update posted

Aug 27, 2026

Last verified

Apr, 2026

Keywords

  • Nasoseptal Flap Harvest
  • Sinonasal Morbidity
  • Extracellular Matrix
  • Endoscopic Skull Base Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-08-27.