Singh Akhil Pratap, Singh Saloni, Malik Ridhima, Gupta Ritu, Pandey Siddharth
Department of ENT and Head Neck surgery Sarojini Naidu Medical College, Moti Katra, Agra, UP India.
Datt Mediproducts Private Limited, 56 Community Centre, East of Kailash, New Delhi, India.
Indian J Otolaryngol Head Neck Surg. 2024 Apr;76(2):1886-1890. doi: 10.1007/s12070-023-04437-2. Epub 2023 Dec 28.
The primary function of nasal packs is to modulate the bleeding, prevent adhesions and obstruction, with least discomfort to the subjects without risking secondary infection. However, both packing and removal of the pack is an unpleasant experience, with the latter being extremely painful. Therefore the need of the hour is a dressing which prioritizes subject comfort without compromising other desired nasal pack properties. Twenty subjects were enrolled in this interventional, open label study. The subjects had 10 hospital visits, starting from baseline (Visit 1) to postoperative day 28 (Visit 10), at regular intervals. The proportion of the population with postoperative pain alleviation and bleeding control failure (within 10 min) were the main objectives. Within 10 min of VELNEZ administration, all 20 participants got their bleeding under control. With VELNEZ, the painful nasal pack removal method was totally avoided because it was biodegradable. No moderate/severe pain, infection and adhesions were reported in any of the subjects, but few subjects reported moderate obstruction until Visit 3 (Discharge Day). In the present study, for participants undergoing nasal surgery, VELNEZ proved to be a secure and reliable nasal pack. : CTRI/2021/09/036437, prospectively registered.
鼻腔填塞物的主要功能是调节出血、防止粘连和阻塞,在不给受试者带来太大不适的情况下,且无继发感染风险。然而,填塞和取出填塞物都是不愉快的经历,后者极其痛苦。因此,当下需要一种敷料,在不影响鼻腔填塞物其他所需特性的前提下,将受试者的舒适度放在首位。20名受试者参与了这项干预性、开放标签研究。受试者从基线(第1次访视)到术后第28天(第10次访视),定期进行10次医院访视。术后疼痛缓解和出血控制失败(10分钟内)的人群比例是主要观察指标。在使用VELNEZ后10分钟内,所有20名参与者的出血均得到控制。由于VELNEZ是可生物降解的,完全避免了痛苦的鼻腔填塞物取出方法。所有受试者均未报告中度/重度疼痛、感染和粘连,但少数受试者在第3次访视(出院日)前报告有中度阻塞。在本研究中,对于接受鼻腔手术的参与者,VELNEZ被证明是一种安全可靠的鼻腔填塞物。:CTRI/2021/09/036437,前瞻性注册。