ArticleCureus2024
A Post-marketing Surveillance, Single-Centric Study to Evaluate the Safety and Tolerability of VELNEZ as a Space-Occupying Dressing Pack After Ear Surgery.
Article in Cureus, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
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Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe 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.
methodA 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.
resultsThe 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.
conclusionVELNEZ is safe and effective as a space-occupying dressing pack after ear surgery and is well-tolerated by patients.
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Registered trials
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