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Clinical Outcomes and Patient Satisfaction With Velnez Versus Nasopore in Nasal Surgery
Sponsor: Ayu, Inc.
Summary
This clinical trial evaluated two absorbable nasal packing materials - VELNEZ and NASOPORE - in adult patients (18-70 years) who underwent nasal surgery, including septoplasty, FESS, or turbinoplasty. The study addressed two core questions: whether VELNEZ offered superior haemorrhage control and faster biodegradation, and whether it reduced postoperative pain, fibrosis, adhesion, and discomfort compared to NASOPORE. Participants were randomised to receive either packing material following surgery. They were monitored on the day of surgery for haemostasis and device performance, then followed up with clinical and endoscopic assessments - including pain scoring and adverse event tracking - through Day 90.
Official title: A Prospective, Open-Labelled, Single-Center, Two-Arm, Randomized Clinical Study to Compare Patient Satisfaction and Clinical Outcome Associated With Two Nasal Packs (VELNEZ Vs NASOPORE) in Nasal Surgery.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-09-11
Completion Date
2025-07-20
Last Updated
2026-05-06
Healthy Volunteers
No
Interventions
VELNEZ Nasal Pack
VELNEZ is a biodegradable composite nasal packing material composed of gelatin, chitosan, polyvinyl alcohol, and psyllium husk. It is designed to fragment and degrade within the nasal cavity after app
NASOPORE Nasal Pack
NASOPORE is a biosynthetic biodegradable polyurethane foam nasal packing material. It absorbs fluids, conforms to the nasal cavity, and gradually fragments over time. The device is used for postoperative bleeding control, support of nasal structures, and facilitation of healing following nasal surgery.
Locations (1)
Hospital Al-Sultan Abdullah, Universiti Teknologi MARA, Jalan Hospital, UiTM Sungai Buloh Campus
Sungai Buloh, Selangor, Malaysia