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Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

NCT05898074 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-09

No results posted yet for this study

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)

Interventions

DEVICE

Non-Absorbable Packing (Silastic Splint)

Participant will have silastic splint applied to nasoseptal flap harvest site

DEVICE

PuraGel (RADA16) Hydrogel

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

Sponsors & Collaborators

  • 3-D Matrix UK Ltd.

    collaborator INDUSTRY

  • Indiana University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-09
Primary Completion
2026-06-09
Completion
2026-06-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05898074 on ClinicalTrials.gov