Overview

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.

Eligibility

Inclusion Criteria:

• Adults aged 18-75 years
• Patients needing nasal surgery that requires bilateral nasal packing: types of operations include septomeatal plasty. The bilateral packing material will be trimmed to fit the size of the patient's wound or nasal cavity, at the physician's discretion.

Exclusion Criteria:

• Severe anatomical abnormalities of the nasal cavity or sinuses, including trauma related structural changes, congenital craniofacial malformations, skull base defects or cerebrospinal fluid (CSF) leak, septal perforation, or other abnormalities that could interfere with the evaluation of study outcomes or pose a safety risk to the subject, as evaluated by the investigator.
• Acute sinusitis with abscess formation or severe mucosal swelling.
• Diagnosed with secondary chronic rhinosinusitis; however, patients with recurrence of the condition requiring additional surgery can be included in the study.
• Benign or malignant tumors in the nasal cavity or sinuses.
• Diagnosis of cystic fibrosis, primary ciliary dyskinesia (including Kartagener syndrome), or other conditions associated with impaired mucociliary clearance.
• Patients with known allergies to collagen.
• Patients receiving systemic corticosteroid therapy within the past 4 weeks, or ongoing corticosteroid treatment for any condition; however, patients using nasal spray therapy are allowed to participate.
• Coagulation disorders and/or receiving anticoagulant therapy which impact the nasal surgery (e.g., International Normalize Ratio \[INR\] \> 1.5). Patients with coagulation function suitable for surgery (INR ≤ 1.5) are eligible.
• Uncontrolled chronic disease with risk factor for postoperative hemorrhage such as cardiovascular disease, diabetes mellitus and hypertension, as evaluated by the investigator.
• Pregnancy or breastfeeding women.
• Presence of any contraindication to surgical intervention, as evaluated by the investigator.
• Unable to comply with the follow-up and postoperative care requirements.
• Any clinically relevant condition, in the investigator's judgment, would interfere with the evaluation of study outcomes or pose a safety risk to the subject.
• Participation in other interventional trials or studies.