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

NCT07560254 | Completed

• 1 other identifier: DMPL/CIP-002-2024/CT/VN
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rhinosinusitis; Sinusitis; Chronic Rhino-sinusitis

Keywords

VELNEZ; NASOPORE; Nasal Packing; Biodegradable Nasal Pack; Functional Endoscopic Sinus Surgery; Septoplasty; Rhino Sinusitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postoperative Pain Assessment using Visual Analogue Scale (VAS)

  From Day 0 to Day 14 post-nasal surgery

• Time to Haemorrhage Control

  Day 0 (Intraoperative)

• Adhesion Formation (Endoscopic Assessment)

  Up to Day 90 post-surgery on post surgery follow up visits

• Endoscopic Healing Assessment

  From Day 7 to Day 90 post-surgery

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From Day 0 to Day 90 post-surgery

Study Arms (2)

Arm 1: VELNEZ Nasal Pack

EXPERIMENTAL

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

Arm 2: NASOPORE Nasal Pack

ACTIVE COMPARATOR

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

Interventions

VELNEZ Nasal Pack DEVICE

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

Also known as: VELNEZ

Arm 1: VELNEZ Nasal Pack

NASOPORE Nasal Pack DEVICE

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.

Also known as: NASOPORE

Arm 2: NASOPORE Nasal Pack

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ayu, Inc.: lead

Study Sites (1)

Hospital Al-Sultan Abdullah, Universiti Teknologi MARA, Jalan Hospital, UiTM Sungai Buloh Campus

Sungai Buloh, Selangor, 47000, Malaysia

Location

MeSH Terms

Conditions

Rhinosinusitis; Sinusitis

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Abdul Azim Al-Abrar Ahmad Kailani

  Universiti Teknologi MARA (UiTM), Selangor, Malaysia

  PRINCIPAL INVESTIGATOR

• Mogana S Rajagopal

  UCSI University, Kuala Lumpur, Malaysia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study followed a parallel assignment model in which participants were randomised in a 1:1 ratio to receive either VELNEZ or NASOPORE as postoperative nasal packing. Each participant was assigned to a single treatment arm and remained in that arm throughout the study; no crossover occurred. The allocation sequence was determined using a predefined randomisation schedule to minimise selection bias and ensure balanced distribution across treatment groups. Given the physical differences between the two devices, blinding was not feasible; the study was therefore conducted in an open-label manner, with both investigators and participants aware of the assigned intervention. Both devices were applied intraoperatively or immediately postoperatively as part of routine surgical care. All participants received standard perioperative and postoperative management, with clinical assessments conducted at predefined follow-up time points to evaluate device performance, outcomes, and safety.

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: September 11, 2024
• Primary Completion: April 11, 2025
• Study Completion: July 20, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)