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 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.