Chronically infected radical mastoidectomy cavity
Conditions
Interventions
Trade Name: NasuMel
Product Name: NasuMel
Pharmaceutical Form: Ear gel
INN or Proposed INN: purfied honey
CAS Number: 8028-66-8
Other descriptive name: HONEY
Concentration unit: ml millilitre(s)
Con
Sponsors
Maastricht Universitary Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is the evaluation of the therapeutic benefit of two repeated cavity injections of NasuMel® Neusgel in comparison to the management with local antibiotic/corticosteroid droplets in the treatment of chronically infected/discharging radical mastoid cavities. ;Secondary Objective: The secondary objectives of the study are (a) eradication of cavity infection by NasuMel®, (b) patient and doctors satisfaction and (c) histologically enhancement of the cavity after the treatment.;Primary end point(s): Number of hospital contacts (time to event) during twelve weeks for infection/discharge of patients with continuous or intermittent infected/discharging radical mastoid cavities treated with NasuMel® or local antibiotics + corticosteroids. ;Timepoint(s) of evaluation of this end point: After 12 weeks after start of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a.Mean and median time to first symptom presentation after initial treatment (first contact after initial treatment with hospital for otologic problems, correlated to the radical cavity). b.Individual patient evaluation of symptoms during the study period. This is defined as difference in VAS score, which are scored on every visit by the patient (4 in total). c.Individual patient evaluation of symptom enhancement after the study period by the VAS. On visit 4 (8 weeks after last treatment) the patient fills in a transitional VAS, as “overall” difference. d.Evaluation of symptom change during the study period by a physician by an approved grading system for infection control in otology (Merchnant et al.33). This score is given at every patient’s visit (4 times in total). e.Eradication of bacteria (pre- and post-study swab, at visit 1 and 3). f.Histo-pathological characteristics of actively infected/discharging radical mastoid cavities compared to symptom free post-treatment cavities (descriptive). At visit 1 and 3. g.Histological samples of the intervention and control group will be compared by three different histological grading scales. At visit 1 and 3. h.Amount of additional medication for problems that are related to otologic diseases. ;Timepoint(s) of evaluation of this end point: After 4, 8 and 12 weeks after start of the study. | — |
Countries
Netherlands
Contacts
Public ContactKeel Neus Oorheelkunde
Academisch ziekenhuis Maastricht
Outcome results
None listed