Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

NCT05898074 | Recruiting FDA Device

• 1 other identifier: 14045
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Modified Lund-Kennedy nasal endoscopy score

  Modified Lund-Kennedy nasal endoscopy score to rate mucosal edema, nasal crusting, and scarring. This will be double blinded (video endoscopy will be performed and scoring will be performed by non-operative surgeon, blinded to the intervention group). This scoring will address wound healing, adhesion formations. Scoring will be performed at 1 week, 4 weeks, and 12 weeks following surgery. The timing of these assessments is based on the routine postoperative follow-up schedule. No additional appointments will be made for the purposes of this study. We will be looking at the change in this score over time. Minimum would be 0. Maximum would be 10. Higher score means worse outcome. The un-abbreviated title is Modified Lund-Kennedy nasal endoscopy score.

  1 week, 4 weeks, and 12 weeks following surgery.

Secondary Outcomes (3)

• Patient-reported pain

  1 week, 4 weeks, and 12 weeks following surgery.

• subjective QOL score

  1 week, 4 weeks, and 12 weeks following surgery.

• Endoscopic grading of mucosalization

  1 week, 4 weeks, and 12 weeks following surgery.

Study Arms (2)

PuraGel (RADA16) Hydrogel

ACTIVE COMPARATOR

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

Device: PuraGel (RADA16) Hydrogel

Non-absorbable Packing (Silastic Splint)

ACTIVE COMPARATOR

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

Device: Non-Absorbable Packing (Silastic Splint)

Interventions

PuraGel (RADA16) Hydrogel DEVICE

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

PuraGel (RADA16) Hydrogel

Non-Absorbable Packing (Silastic Splint) DEVICE

Participant will have silastic splint applied to nasoseptal flap harvest site

Non-absorbable Packing (Silastic Splint)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• 3-D Matrix UK Ltd.: collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Skull Base Neoplasms; Cerebrospinal Fluid Leak; Hypertrophy

Condition Hierarchy (Ancestors)

Skull Neoplasms; Bone Neoplasms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Pathological Conditions, Anatomical

Central Study Contacts

Satyan Sreenath, MD

CONTACT

(317) 944-0457; ssreenat@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This will be double blinded (video endoscopy will be performed and scoring will be performed by non-operative surgeon, blinded to the intervention group).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Otolaryngology--Head and Neck Surgery

Model Details: Prospective, Randomized Cohort Study

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 12, 2023
• Study Start: October 9, 2023
• Primary Completion (Estimated): June 9, 2026
• Study Completion (Estimated): June 9, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)