Efficacy and Safety of NasoAid® After Nasal Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMaxigen Biotech Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
NasoAid® Intranasal Splint
DeviceNasoAid® 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
Device"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.
Treatment groups
154 Participants
are divided into 2 treatment groupsGroup A: Treatment group (NasoAid)Experimental treatment 1 intervention
Group B: Control group (NasoPore)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hemostasis Rate at 24 Hours After Nasal Packing
Hemostasis will be assessed using a four-grade bleeding scale: 0 = no bleeding; 1 = minimal bleeding confined to the nasal cavity; 2 = moderate bleeding extending outside the nasal cavity without requiring repacking; and 3 = severe bleeding requiring repacking. The hemostasis rate will be compared between the NasoAid and NasoPore groups.
Time frame
24 hours after nasal packingSecondary outcomes
1
Hemostasis Rate at 2, 12, and 48 Hours After Nasal Packing
Hemostasis will be assessed using the same four-grade bleeding scale as the primary outcome: 0 = no bleeding; 1 = minimal bleeding confined to the nasal cavity; 2 = moderate bleeding extending outside the nasal cavity without requiring repacking; and 3 = severe bleeding requiring repacking. The hemostasis rates will be compared between the NasoAid and NasoPore groups.
Time frame
2 hours, 12 hours, and 48 hours after nasal packing2
Endoscopic Nasal Assessment Score
Endoscopic nasal assessment will evaluate four parameters: edema, discharge, scarring, and crusting. Each parameter is scored from 0 to 2, with higher scores indicating greater severity. The score for each side of the nasal cavity ranges from 0 to 8, resulting in a total score ranging from 0 to 16. Scores will be compared between the NasoAid and NasoPore groups.
Time frame
Pre-surgery and at Weeks 2, 4, 8, and 12 after surgery3
Remnant Nasal Packing Material
The amount of remnant nasal packing material in the middle meatus of each side will be assessed by nasal endoscopy before suction or removal. The remaining amount is graded as 0 = none, 1 = 25%, 2 = 25-50%, 3 = 50-75%, and 4 = greater than 75%. The ease of removing the nasal packing by suction or forceps will also be evaluated using a 0-to-10 scale, with 0 indicating very easy and 10 indicating extremely difficult.
Time frame
Week 1 after surgery4
Patient-Reported Visual Analog Scale (VAS) of General Assessment
Subjects will rate four aspects of their postoperative condition using 0-to-10 visual analog scales: severity of nasal symptoms, discomfort caused by nasal symptoms, discomfort caused by olfactory abnormalities, and the impact of nasal symptoms on sleep. Higher scores indicate greater symptom severity, discomfort, or impact.
Time frame
Preo-surgery and at Weeks 1, 2, 4, 8, and 12 after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov