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Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

Indiana University · with 3-D Matrix UK Ltd. · NCT05898074

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
30
US sites recruiting
1
Study start
October 9, 2023
Record last updated
August 27, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Non-Absorbable Packing (Silastic Splint); PuraGel (RADA16) Hydrogel

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

Study contacts (from the official record)

  • Satyan Sreenath, MD · (317) 944-0457 · ssreenat@iu.edu
All healthy volunteers studies in Indiana →
Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery (NCT05898074) | Bored Studies