Open label, interventional, single arm multicentric clinical study to analyze the potency of VELNEZ nasal pack, post-nasal surgery.

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: VELNEZ, a fragmentable nasal pack, is comfortable, safe, and effective against postsurgery bleeding and pain.