A Post-marketing Surveillance, Single-Centric Study to Evaluate the Safety and Tolerability of VELNEZ as a Space-Occupying Dressing Pack After Ear Surgery

Abstract

Purpose: The purpose of this study was to evaluate the safety and tolerability of VELNEZ (Datt Mediproducts Pvt. Ltd., New Delhi, India) as a space-occupying dressing for controlling hemorrhage after ear surgery. Method: A total of 21 patients were included in an open-label, interventional, single-arm post-marketing surveillance study to investigate the safety and efficacy of the VELNEZ ear pack. The patients were questioned for collecting data related to the subject's safety and comfort, adverse events, site assessment, and otoscopic examination from discharge day to last follow-up (eight follow-up visits) at regular intervals. The standardized questionnaires for VELNEZ tolerability (pain/pressure effect, infection, and general satisfaction) were used after ear surgery. Results: The average hemorrhage control time was 1.08 ± 0.16 minutes. None of the subjects reported moderate pain at any of the study visits following surgery. This biodegradable ear pack had an average disintegration time of 25.4 days in the ear cavity. No postoperative adverse events or serious adverse events were observed. Conclusion: VELNEZ is safe and effective as a space-occupying dressing pack after ear surgery and is well-tolerated by patients.