Cholesteatoma, Middle Ear
Conditions
Interventions
This is a randomized, placebo controlled, double blind clinical trial. A total of 50 patients over 18 years with chronic otorrhea that has not improved with clinical treatment and who were submitted a
D02.455.326.146.100.050.490
Sponsors
Escola Paulista de Medicina da Universidade Federal de São Paulo
Escola Paulista de Medicina da Universidade Federal de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients over 18 years; middle ear cholesteatoma diagnosed; canal wall down mastoidectomy performed at least 6 months before inclusion in the study by the same three otologic surgeons at Escola Paulista de Medicina da Universidade Federal de São Paulo; chronic otorrhea (= 3 months) with purulent drainage refractory to medical treatment; audiometry test conducted in the postoperative period and within 6 months before inclusion in the study; patent meatoplasty allowing complete visualization of the surgical cavity
Exclusion criteria
Exclusion criteria: Use of systemic antibiotics and/or topical antibiotics, steroids or antifungals within 30 days prior to inclusion in the study; fever or perichondritis at the time of the study; allergy or hypersensitivity to sodium 2-mercaptoethanesulfonate (MESNA) or compounds containing the thiol group; malformation of the external auditory meatus or stenosis of the meatoplasty preventing appropriate visualization of the open mastoid cavity; fungal infection in the cavity identified by otoscopy; peripheral facial palsy; dehiscence of semicircular canal or facial nerve canal observed on temporal bone computed tomography or during mastoidectomy; profound sensorineural hearing loss in the ear opposite to the one included in the study; history of psychiatric illness; pregnancy; desire to become pregnant or breastfeeding during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An improvement in otorrhea is expected, assessed by otoscopy, and indicated by a reduction of at least 1 point in the otoscopy score | — |
Secondary
| Measure | Time frame |
|---|---|
| A decrease in the discomfort caused by the otorrhea is expected, assessed using a visual analog scale, with a reduction of at least 1 point on the scale;Bacterial biofilms are expected to be found in the otorrhea samples collected, and a change in the bacterial biofilm conformation is expected to be identified after the application of MESNA, using a microscope to visualize the disaggregated biofilm | — |
Countries
Brazil
Contacts
Public ContactAdriana Perez Ferreira Neto
Escola Paulista de Medicina-Universidade Federal de São Paulo
Outcome results
None listed