Clinical Outcomes and Patient Satisfaction With Velnez Versus Nasopore in Nasal Surgery

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.

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.

Study Overview

• Status: Completed
• Conditions: Sinusitis; Rhinosinusitis; Chronic Rhino-sinusitis
• Intervention / Treatment: Device: VELNEZ Nasal Pack; Device: NASOPORE Nasal Pack

Detailed Description

This study was a prospective, randomised, open-label, single-centre, two-arm parallel clinical investigation conducted in a post-market setting. It was designed to evaluate and compare the clinical performance of two biodegradable nasal packing materials - VELNEZ and NASOPORE - following routine nasal surgical procedures under real-world conditions.

Rationale and background Nasal packing is routinely employed after septoplasty, FESS, and turbinoplasty to achieve haemostasis, support mucosal healing, and prevent postoperative complications including adhesions and septal haematoma. Conventional non-absorbable packing materials, while effective for haemostasis, are associated with significant patient discomfort, pain at removal, mucosal trauma, and risk of delayed healing. Biodegradable alternatives were developed to address these limitations by obviating the need for mechanical removal and providing a more favourable postoperative environment.

Investigational devices VELNEZ is a biodegradable composite nasal packing material comprising gelatin, chitosan, polyvinyl alcohol, and psyllium husk. Following placement, it was designed to fragment and gradually dissolve within the nasal cavity over several days. Its composition was intended to deliver effective haemostasis, physically separate mucosal surfaces to reduce adhesion formation, and support tissue regeneration - all without requiring removal, thereby minimising procedure-related trauma and improving patient tolerability.

NASOPORE is a biosynthetic, biodegradable polyurethane foam with established clinical use. Its hydrophilic properties allowed it to absorb fluids and conform to the contours of the nasal cavity, providing mechanical support and haemostatic function. Degradation occurred through fragmentation over time, though the rate and completeness of dissolution varied across patients.

Study design and randomisation Participants were assigned in a 1:1 ratio to receive either VELNEZ or NASOPORE as postoperative nasal packing immediately following surgery. Randomisation was performed to minimise selection bias. Given the physical and visual differences between the two materials, blinding of investigators and participants was not feasible; the study was therefore conducted in an open-label manner.

Clinical assessments and follow-up

Assessments were conducted perioperatively and at scheduled postoperative visits through the final follow-up at Day 90. The evaluation framework covered the following domains:

Device performance: Ease of placement, conformability to nasal anatomy, and haemostatic effectiveness were assessed perioperatively. Degradation profile was monitored clinically at each follow-up; irrigation or manual intervention was performed where incomplete dissolution was observed.

Mucosal and structural healing: Endoscopic examination of the surgical site was performed at applicable visits to evaluate mucosal condition, presence of oedema, secretions, fibrosis, scar formation, and adhesion development. Any pressure-related discomfort or structural changes were documented.

Patient-reported outcomes: Symptom burden and quality of life were assessed using the Sino-Nasal Outcome Test (SNOT-22), a validated instrument for sinonasal conditions. Pain and tolerability were evaluated using standardised pain assessment scales at defined time points.

Safety monitoring: Adverse events and serious adverse events were recorded throughout the study. Device-related complications - including infection, hypersensitivity reactions, and signs of delayed healing - were specifically monitored. Vital signs, physical examinations, and laboratory evaluations were conducted per routine clinical practice.

Statistical approach Continuous variables were summarised using descriptive statistics and compared between groups using parametric or non-parametric tests, selected based on data distribution. Categorical variables were analysed using Chi-square or Fisher's exact test, as appropriate. All analyses were conducted at a two-sided significance level.

Ethical and regulatory conduct The study was conducted in accordance with Good Clinical Practice (GCP) and the ethical principles of the Declaration of Helsinki. Institutional Ethics Committee approval was obtained prior to initiation. All participants provided written informed consent before enrolment.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Selangor
    • Sungai Buloh, Selangor, Malaysia, 47000
      • Hospital Al-Sultan Abdullah, Universiti Teknologi MARA, Jalan Hospital, UiTM Sungai Buloh Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants eligible for the use of a nasal pack (either VELNEZ or Nasopore) in routine clinical practice after a planned nasal surgery.
• Male and female in the age group of 18 to 70 years. (Both Included)
• Participants or their LAR who can provide informed consent form in writing.
• Participants who allow their study data to be collected at pre-defined follow-up period.

Exclusion Criteria:

Participants who are unable to be treated with VELNEZ, or Nasopore nasal pack in routine clinical practice after a planned surgery.

• Participant's/ legal guardian (LAR) who cannot provide informed Consent written.
• Participant unwilling or unable to comply with the postoperative visits necessary for data collection.
• Participant with an active infection at the surgery site.
• Participant with a history of asthma.
• Pregnant or lactating Females
• Participant who are on aspirin or anti-platelet drugs therapy.
• Participant positive for HIV, HCV, VDRL, HBs Ag.
• Participant who is allergic (Hypersensitive) to any of the ingredients of the nasal packs.
• Participant with bleeding disorders.
• Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for inclusion (e.g., a chronic, relapsing or hereditary disease that may interfere with the outcome of the study).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: VELNEZ Nasal Pack; Participants undergoing planned nasal surgery received the VELNEZ biodegradable nasal pack, applied intraoperatively or immediately postoperatively in accordance with standard surgical practice. The device was intended to provide haemostasis, support mucosal healing, and reduce postoperative complication	Device: 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; Other Names: VELNEZ
Active Comparator: Arm 2: NASOPORE Nasal Pack; Participants undergoing planned nasal surgery received the NASOPORE biodegradable nasal pack, applied intraoperatively or immediately postoperatively in accordance with standard surgical practice. The device was intended to provide haemostasis and structural support within the nasal cavity during the healing process.	Device: 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.; Other Names: NASOPORE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success of Nasal Pack	Proportion of participants achieved successful clinical outcome defined as complete degradation of the nasal pack within 7 days without device-related adverse events, along with acceptable levels of fibrosis and scar formation, absence of moderate to severe postoperative pain, and no significant breathing discomfort due to pressure effect	Up to Day 90 post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Haemorrhage Control	Time (in minutes) from application of the nasal pack at completion of surgery to achievement of complete haemostasis, as assessed by the operating surgeon	Day 0 (Intraoperative)
Adhesion Formation (Endoscopic Assessment)	Incidence and severity of nasal adhesions assessed using endoscopic examination during follow-up visits.	Up to Day 90 post-surgery on post surgery follow up visits
Endoscopic Healing Assessment	Assessment of nasal mucosal healing based on endoscopic findings including mucosal oedema, nasal secretions, and presence of polyps during follow-up visits	From Day 7 to Day 90 post-surgery
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)	Number and proportion of participants experiencing adverse events, serious adverse events, or device-related complications during the study period.	From Day 0 to Day 90 post-surgery
Postoperative Pain Assessment using Visual Analogue Scale (VAS)	Patient-reported pain levels will be assessed using the Visual Analogue Scale (VAS), a 10 cm horizontal line anchored by "no pain" (score = 0) and "worst imaginable pain" (score = 10). The total score ranges from 0 to 10. Higher scores indicate greater pain intensity and worse outcome (lower tolerability of the nasal pack).	From Day 0 to Day 14 post-nasal surgery

Collaborators and Investigators

• Sponsor: Ayu, Inc.
• Investigators: Principal Investigator: Abdul Azim Al-Abrar Ahmad Kailani, Universiti Teknologi MARA (UiTM), Selangor, Malaysia; Study Director: Mogana S Rajagopal, UCSI University, Kuala Lumpur, Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Actual): April 11, 2025
• Study Completion (Actual): July 20, 2025

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Functional Endoscopic Sinus Surgery; Septoplasty; Nasal Packing; VELNEZ; NASOPORE; Biodegradable Nasal Pack; Rhino Sinusitis
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Paranasal Sinus Diseases; Rhinosinusitis; Sinusitis
• Other Study ID Numbers: DMPL/CIP-002-2024/CT/VN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to confidentiality considerations. Aggregated study results will be made available through publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No