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Efficacy and Safety of NasoAid® After Nasal Surgery
Sponsor: Maxigen Biotech Inc.
Summary
The goal of this clinical trial is to evaluate the effectiveness and safety of collagen-based absorbable nasal packing (NasoAid®) after nasal surgery. The main question it aims to answer are: * The hemostasis 2, 12, 24, 48 hours after nasal packing. * The endoscopic nasal assessments scores. * The remnant percentage of nasal packing material. * Patient-reported Visual Analog Scale (VAS) scores for general assessment. * Patient-reported outcomes, including the Sino-Nasal Outcome Test-22 (SNOT-22), Nasal Obstruction Symptom Evaluation (NOSE), and Total Nasal Symptom Score (TNSS). * The incidences of safety indicators. Participants will be randomized into either experiment group or control group, receive nasal packing at Day0, and re-visited on week 1, 2, 4, 8 and 12 after nasal surgery. Researchers will compare if NasoAid® is non-inferiority to NasoPore.
Official title: Efficacy and Safety of Collagen-Based Absorbable Nasal Packing (NasoAid®) After Nasal Surgery: A Prospective, Single-Blind, Randomized Controlled Multi-Center Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
154
Start Date
2026-08-24
Completion Date
2027-07-31
Last Updated
2026-10-06
Healthy Volunteers
No
Conditions
Interventions
NasoAid® Intranasal Splint
NasoAid® Intranasal Splint is an absorbable nasal packing device composed of collagen and carboxymethyl cellulose. Nasal packing will be applied at the end of surgery. The packing may be trimmed or reshaped intraoperatively by the surgeon to fit the cavity.
"Stryker" NasoPore Nasal Dressing
"Stryker" NasoPore Nasal Dressing is a bioresorbable synthetic polyurethane foam nasal packing device. Nasal packing will be applied at the end of surgery. The packing may be trimmed or reshaped intraoperatively by the surgeon to fit the cavity.
Locations (3)
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan