Bellad Shama, Parusharam Nagula, Dhyani Vineeta, Bablani Pankaj, Pandey Siddharth
Department of ENT Jawaharlal Nehru Medical College Belagavi Karnataka India.
Department of ENT Mahatma Gandhi Memorial Hospital Warangal Telangana India.
World J Otorhinolaryngol Head Neck Surg. 2023 Jul 4;10(3):180-186. doi: 10.1002/wjo2.115. eCollection 2024 Sep.
Nasal packs are central to nasal surgeries. Primarily, these packs function by controlling bleeding, modulating pain and reducing adhesions postsurgery. However, the major setback of the currently used conventional nasal packs is the unbearable pain the patient undergoes upon removal of these packs. To overcome this shortcoming a variety of biodegradable packs have emerged. This study was aimed at evaluating the safety, efficacy and tolerability of VELNEZ nasal packs. VELNEZ, a patented Datt Mediproducts Pvt. Ltd. nasal pack, is one of its kind biodegradable composite that fragments within a few days of application.
Eighty patients were included in an open label, interventional, single arm clinical study using clinical endpoints to investigate the safety and efficacy of nasal pack VELNEZ. The patients were questioned using a visual analog scale from discharge day to 28th postoperative day (9 follow-up visits) at regular intervals. The standardized questionnaires for hemorrhage control, relief from postoperative pain, moderate obstruction, and pain were used.
A total of 76 patients were enrolled in the study and 74 patients completed the study. VELNEZ nasal pack played a significant role in controlling hemorrhage and reducing postoperative pain. The average hemorrhage control time was 7.49 ± 3.90 min with only 34.24% of population complaining of pain on the sixth day of surgery (follow-up 4). Forteen days postsurgery only 10.95% of subject population complained of postoperative pain. This biodegradable composite has an average fragmentation time of 4.7 days in the nasal cavity. In addition, this study did not observe any postoperative adverse events or serious adverse events.
VELNEZ, a fragmentable nasal pack, is comfortable, safe, and effective against postsurgery bleeding and pain.
鼻腔填塞物是鼻腔手术的核心。这些填塞物主要通过控制出血、减轻疼痛和减少术后粘连来发挥作用。然而，目前使用的传统鼻腔填塞物的主要缺点是患者在取出这些填塞物时会经历难以忍受的疼痛。为了克服这一缺点，出现了多种可生物降解的填塞物。本研究旨在评估VELNEZ鼻腔填塞物的安全性、有效性和耐受性。VELNEZ是Datt Mediproducts Pvt. Ltd.公司的一款获得专利的鼻腔填塞物，是一种独特的可生物降解复合材料，在应用几天后会破碎。
80名患者纳入一项开放标签、干预性、单臂临床研究，使用临床终点来研究VELNEZ鼻腔填塞物的安全性和有效性。从出院日到术后第28天（9次随访），定期使用视觉模拟量表对患者进行询问。使用了关于出血控制、术后疼痛缓解、中度鼻塞和疼痛的标准化问卷。
共有76名患者参与研究，74名患者完成研究。VELNEZ鼻腔填塞物在控制出血和减轻术后疼痛方面发挥了重要作用。平均出血控制时间为7.49±3.90分钟，只有34.24%的患者在手术第六天（随访4）抱怨疼痛。术后14天，只有10.95%的受试者抱怨术后疼痛。这种可生物降解复合材料在鼻腔内的平均破碎时间为4.7天。此外，本研究未观察到任何术后不良事件或严重不良事件。
VELNEZ，一种可破碎的鼻腔填塞物，在应对术后出血和疼痛方面舒适、安全且有效。
