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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Clinical Success of Nasal Pack
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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
干预措施: VELNEZ Nasal Pack (Device)
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.
干预措施: NASOPORE Nasal Pack (Device)
结局指标
主要结局
Clinical Success of Nasal Pack
时间窗: Up to Day 90 post-surgery
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
次要结局
- Postoperative Pain Assessment(From Day 0 to 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)
- Postoperative Pain Assessment using Visual Analogue Scale (VAS)(From Day 0 to Day 14 post-nasal surgery)