ABSTRACT
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. Trial Registration: CTRI/2021/09/036437, prospectively registered.
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.
ABSTRACT
The tympanic membrane (TM) undergoes a number of pathological changes in middle ear disease which can be detected by a video-otoendoscope. Middle ear disease is also accompanied by changes in middle ear pressure which can be assessed by tympanometry. The objectives of this study were to find the correlation between video-otoendoscopy and tympanometry in acute middle ear infections and to deduce which of the two is more efficient and reliable for early diagnosis. 75 patients with AOM or OME were included over 1 year where each patient was followed for 21 days. Detailed history and clinical examination with videootoendoscope and tympanometry was done on each visit. Each TM was graded using OMGRADE scale. Symptoms and clinical findings consistent with acute otitis media were given a clinical score (CO Score). The results were collected and correlation between video-otoendoscopy and tympanometry was determined and their individual sensitivity, specificity and diagnostic accuracy was calculated. The sensitivity, specificity and diagnostic accuracy for tympanometry and video-otoendoscopy was calculated individually for each of the 4 visits and positive correlation between the 2 was found. Our study showed that tympanometry had a higher overall sensitivity than video-otoendoscopy. While, video-otoendoscopy showed a higher specificity than Tympanometry. Otoendoscopy is good for ruling out AOM/OME but cannot rule out persisting Middle Ear Effusion and Tympanometry is a better tool for detecting MEE but cannot differentiate well between AOM and OME. We found that tympanometry plus otoendoscopy together greatly increase the chances of detecting AOM and OME thus improving diagnostic accuracy, reducing financial costs associated with over or mis-diagnosis.
