asuMel® Gel - a Medical Grade Honey Product for the Treatment of Chronically Infected Radical Mastoid Cavities - NasuMel® Gel - Treatment of Radical Mastoid Cavities

Maastricht Universitary Medical Centre0 个研究点目标入组 100 人开始时间: 2011年4月27日最近更新: 2024年2月26日

试验速览

暂无简介。

•a.Previous operation or reoperation of the middle ear and mastoid bone with the creation of a radical mastoid cavity.
•b.Presentation with symptoms of an infected/discharging cavity (otorrhea (defined as actual discharge, feeling of discharge by the patient, recent detection of signs of discharge by the patient on pillow or clothes), signs of infection during otologic exploration) on the first visit in association with the study.
•c.No other invasive otologic operations after the introduction of the radical cavity (this does not include reoperations).
•d.Age between 18 – 80 years.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•a.Not fulfilling inclusion criteria.
•b.Any other actual experimental” treatment for mastoid cavity infection/discharge.
•c.Abscess or infection processes in the mastoid/temporal bone or structures directly adjacent to the radical cavity.
•d.Chronic intake (cumulative > 5 days) of non-steroidal anti-inflammatory drugs, corticosteroids (systemic or in open cavities, not defined as control treatment) or other medications interfering with the immune system or with a systemic antimicrobial effect (e.g. antibiotics, not defined as control treatment).
•e.Known allergic reaction to honey.
•f.Minors and/or incapacitated adults.

发起方

Maastricht Universitary Medical Centre