RECRUITING

Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

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Conditions

Skull Base NeoplasmsCerebrospinal Fluid LeakageNasal; Hypertrophy, Mucous Membrane (Septum)Nasoseptal Flap HarvestSinonasal MorbidityExtracellular MatrixEndoscopic Skull Base Surgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-10-09
Study Completion:2025-10-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05898074

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient is 18 years of age or older
  2. * Patient is undergoing endoscopic endonasal approach for the management of a skull base tumor or cerebrospinal fluid leak. Nasoseptal Flap must be harvested.
  3. * Patient is undergoing surgery via bi-nostril approach requiring bilateral surgical dissection of the nasal cavity in approach to the skull base
  1. * 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
  2. * Patient has had prior sinonasal surgery or has undergone sinonasal radiation treatment
  3. * Patient has a known coagulation disorder or immune deficiency.

Contacts and Locations

Study Contact

Satyan Sreenath, MD
CONTACT
(317) 944-0457
ssreenat@iu.edu

Study Locations (Sites)

Indiana University
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

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

Study Start Date2023-10-09
Study Completion Date2025-10-09

Study Record Updates

Study Start Date2023-10-09
Study Completion Date2025-10-09

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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