Back to search results

Study of PuraGel (RADA16) Hydrogel in Endoscopic Skull Base Surgery

This study is looking at how well a product called PuraGel (RADA16) Hydrogel helps people heal after endoscopic skull base surgery. This surgery is done through the nose to treat skull base tumors or cerebrospinal fluid (CSF) leaks. During the surgery, a piece of tissue called a nasoseptal flap is often used. Researchers want to see if PuraGel helps this area heal faster and reduces problems like crusting or scarring, compared to a standard non-absorbable packing (Silastic Splint). The study will measure healing using a nasal endoscopy score at 1 week, 4 weeks, and 12 weeks after surgery. You may be able to join if you are 18 or older, having this type of surgery, and a nasoseptal flap is harvested. The study aims to enroll 30 participants, but its current status is unclear.

Study design
This study is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.
What's involved
Participants will have either a Silastic Splint or PuraGel (RADA16) Hydrogel applied during surgery. Healing will be checked with a nasal endoscopy at 1 week, 4 weeks, and 12 weeks after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 weeks after surgery to assess healing.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05898074

Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

Recruiting
NAAges 18+InterventionalTreatment
Indiana University
~30 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Non-Absorbable Packing (Silastic Splint)PuraGel (RADA16) Hydrogel

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Modified Lund-Kennedy nasal endoscopy score
Measured over 1 week, 4 weeks, and 12 weeks following surgery.

Conditions

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

Explore related trials

Cerebrospinal Fluid LeakageSkull Base Neoplasm

Where it's being run

1 sites across 1 states
Indiana1

Who to contact

Satyan Sreenath, MD
[email protected]
(317) 944-0457
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in Modified Lund-Kennedy nasal endoscopy score1 week, 4 weeks, and 12 weeks following surgery.

    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.