Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery
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 Start (Actual) 9 October 2023
🗓️ Primary Completion (Estimated) 9 October 2025
✅ Study Completion (Estimated) 9 October 2025
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Indianapolis, Indiana, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 22 May 2023
  • First Submitted that Met QC Criteria 6 June 2023
  • First Posted 12 June 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 June 2024
  • Last Update Posted 1 July 2024
  • Last Verified June 2024