■鼻包是鼻部手术的核心。首先,这些包通过控制出血来发挥作用,调节疼痛和减少术后粘连。然而,目前使用的传统鼻包的主要挫折是患者在移除这些鼻包时经历的难以忍受的疼痛。为了克服这个缺点,已经出现了各种可生物降解的包装。这项研究旨在评估安全性,VELNEZ鼻包的疗效和耐受性。VELNEZ,获得专利的DattMediproductsPvt.有限公司鼻包,是一种可生物降解的复合材料,可在应用后几天内破碎。
■80名患者被纳入开放标签,介入,使用临床终点进行单臂临床研究,以研究鼻包VELNEZ的安全性和有效性。从出院日至术后第28天(9次随访)定期使用视觉模拟量表询问患者。标准化的出血控制问卷,缓解术后疼痛,中度梗阻,和疼痛被使用。
■共76名患者纳入研究,74名患者完成研究。VELNEZ鼻包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%的人群在手术的第六天抱怨疼痛(随访4)。术后四天,只有10.95%的受试者抱怨术后疼痛。这种可生物降解的复合材料在鼻腔中的平均碎裂时间为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,一个破碎的鼻包,很舒服,安全,对术后出血和疼痛有效。
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: VELNEZ, a fragmentable nasal pack, is comfortable, safe, and effective against postsurgery bleeding and pain.