NasoAid vs NasoPore after Nasal Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, single-blind, multicenter non-inferiority trial comparing two nasal packing materials following nasal surgery that requires bilateral packing. Participants will receive either NasoAid® or NasoPore and will be followed for 12 weeks, with hemostasis checked at 2, 12, 24, and 48 hours, remnant packing assessed at day 7, and endoscopic assessments at weeks 2, 4, 8, and 12. Patient-reported outcomes including VAS, SNOT-22, NOSE, and TNSS will be collected pre-surgery and at multiple post-surgery visits. Safety data and adverse events will be monitored throughout the study.

Why it matters

Who can join: the full rules

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.

Where it's running

• National Taiwan University Hospital
  Taipei, Taiwan Recruiting
• Chang Gung Memorial Hospital, Linkou
  Taoyuan, Taiwan Recruiting
• Taipei Veterans General Hospital
  Taipei, Taiwan Not yet recruiting

Study contacts

• Study coordinator: LiRong Chen
• Email: lirong.chen@mbi.com.tw
• Phone: +88633287222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.