RECRUITING

Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

Description

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 NeoplasmsCerebrospinal Fluid LeakageNasal; Hypertrophy, Mucous Membrane (Septum)
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Related Conditions:

Skull Base NeoplasmsCerebrospinal Fluid LeakageNasal; Hypertrophy, Mucous Membrane (Septum)

Study Overview

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Study Details

Study overview

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.

Novel Application of RADA16 Hydrogel in Reducing Sinonasal Morbidity After Endoscopic Skull Base Surgery

Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

Condition
Skull Base Neoplasms
Intervention / Treatment

-

Contacts and Locations

Indianapolis

Indiana University, Indianapolis, Indiana, United States, 46202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Indiana University,

Study Record Dates

2025-10-09