Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

NCT ID: NCT05898074

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-09
• Study Completion Date: 2025-10-09

Brief 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.

Detailed Description

Briefly, multiple agents exist and have been long-studied in endoscopic sinus and septal surgery, which include non-absorbable agents and biodegradable, absorbable synthetic agents including extracellular matrix (ECM) based compounds and synthetic biopolymers. The goal of these agents has often been to reduce sinonasal crusting, postoperative bleeding, and synechia formation. With advancements in postoperative adjuncts, many options now exist for postoperative sinonasal packing including medicated products such as steroid-impregnated stents and chitosan-based absorbable packs.

Lastly, with respect to intra-operative adjuncts designed to foster healing in the postoperative period, PuraGel, a RADA16 polypeptide hydrogel, was identified as an ECM-based solution, which aids in wound healing, adhesion prevention, and hemostasis at the completion of the case. In hydrogel format, this agent forms a synthetic matrix that serves as a scaffold for mucosal healing while serving as a mechanical barrier on tissue surfaces, thereby limiting scarring. To date, there have been no studies evaluating the role of this gel-based compound in the postoperative period in endoscopic skull base surgery.

Thus, amongst all of these agents that have been previously studied to some degree in patients undergoing endoscopic sinus surgery, there has been limited study on their role in endoscopic skull base surgery and utility in reducing sinonasal morbidity in the postoperative setting. Therefore, our goal was to investigate and compare the impact of varying sinonasal agents in the nasal cavity following endoscopic skull base surgery. We hypothesize that the absorbable, ECM-based gel compound (PuraGel) demonstrates an improvement on postoperative healing rate and sinonasal crusting with reduced patient morbidity and improved patient comfort when compared to non-absorbable agents.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PuraGel (RADA16) Hydrogel

Participant will have PuraGel (RADA16) Hydrogel applied to the nasoseptal flap harvest site following endoscopic skull base surgery

Group Type: ACTIVE_COMPARATOR

PuraGel (RADA16) Hydrogel

Intervention Type: DEVICE

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

Non-absorbable Packing (Silastic Splint)

Participant will have a silastic splint (Non-Absorbable Packing) applied to the nasoseptal flap harvest site following endoscopic skull base surgery with no additional packing or agent

Group Type: ACTIVE_COMPARATOR

Non-Absorbable Packing (Silastic Splint)

Intervention Type: DEVICE

Participant will have silastic splint applied to nasoseptal flap harvest site

Interventions

Non-Absorbable Packing (Silastic Splint)

Participant will have silastic splint applied to nasoseptal flap harvest site

Intervention Type: DEVICE

PuraGel (RADA16) Hydrogel

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

3-D Matrix UK Ltd.

INDUSTRY

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Satyan B. Sreenath

Assistant Professor, Department of Otolaryngology--Head and Neck Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Indiana University

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Satyan Sreenath, MD

Role: CONTACT

ssreenat@iu.edu

(317) 944-0457

Other Identifiers

14045

Identifier Type: -

Identifier Source: org_study_id