Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

Trial Title: Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

NCT ID: NCT05898074

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

Conditions: Official terms:
Skull Base Neoplasms
Cerebrospinal Fluid Leak
Hypertrophy

Conditions: Keywords:
Nasoseptal Flap Harvest
Sinonasal Morbidity
Extracellular Matrix
Endoscopic Skull Base Surgery

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Prospective, Randomized Cohort Study

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking description: This will be double blinded (video endoscopy will be performed and scoring will be performed by non-operative surgeon, blinded to the intervention group).

Intervention:

Intervention type: Device
Intervention name: Non-Absorbable Packing (Silastic Splint)
Description: Participant will have silastic splint applied to nasoseptal flap harvest site
Arm group label: Non-absorbable Packing (Silastic Splint)

Intervention type: Device
Intervention name: PuraGel (RADA16) Hydrogel
Description: Participant will have PuraGel (RADA16) Hydrogel applied to the nasoseptal flap harvest site
Arm group label: PuraGel (RADA16) Hydrogel

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Indiana University

Address:
City: Indianapolis
Zip: 46202
Country: United States

Status: Recruiting

Start date: October 9, 2023

Completion date: October 9, 2025

Lead sponsor:
Agency: Indiana University
Agency class: Other

Collaborator:
Agency: 3-D Matrix Medical Technology
Agency class: Other

Source: Indiana University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05898074